Labels & MSDS

Comparing data of MSDS for lindane shampoo:

KWELL SHAMPOO	LINDANE USP 1% SHAMPOO	LINDANE SHAMPOO USP,1%
Route Of Entry - Inhalation: NO Route Of Entry - Skin: YES Route Of Entry - Ingestion: YES	Route Of Entry - Inhalation: YES Route Of Entry - Skin: YES Route Of Entry - Ingestion: NO	Route Of Entry - Inhalation: YES Route Of Entry - Skin: YES Route Of Entry - Ingestion: YES
Health Haz Acute And Chronic: ACUTE: MAY CAUSE SKIN IRRITATION. MAY BE ABSORBED THROUGH THE SKIN TO CAUSE CENTRAL NERVOUS SYSTEM EXCITATION. CONTACT MAY CAUSE EYE IRRITATION.	Health Haz Acute And Chronic: LINDANE MAY BE ABSORBED THROUGH THE SKIN. CENTRAL NERVOUS SYSTEM EXCEITATION. LINDANE IS SECRETED IN HUMAN BREAST MILK.	Health Haz Acute And Chronic: CENTRAL NERVOUS SYSTEM DEPRESSION.
Carcinogenicity - NTP: YES Carcinogenicity - IARC: NO Carcinogenicity - OSHA: NO	Carcinogenicity - NTP: YES Carcinogenicity - IARC: NO Carcinogenicity - OSHA: YES	Carcinogenicity - NTP: YES Carcinogenicity - IARC: NO Carcinogenicity - OSHA: NO
Explanation Carcinogenicity: NTP LISTS LINDANE AS AN ANTICIPATED CARCINOGEN. EPA LISTS LINDANE AS A POSSIBLE CARCINOGEN.	Explanation Carcinogenicity: TERATOGENI EFFECTS: PREGNANCY CATERGORY B. LINDANE IS SECRETED IN HUMAN BREAST MILK.	Explanation Carcinogenicity: THE NATIONAL TOXICOLOGY PROGRAM HAS CLASSIFIED LINDANE AS A SUBSTANCE THAT MAY REASONABLY BE HUMAN CARCINOGEN.
Signs/Symptoms Of Overexp: SKIN: RASH, ITCHING. INGESTION: CONVULSIONS.	Signs/Symptoms Of Overexp: CONVULSIONS.	Signs/Symptoms Of Overexp: SKIN RASH. DIZZINESS, FAST HEARTBEAT, MUSCLE CRAMPS, NERVOUSNESS, VOMITING.
Med Cond Aggravated By Exp: NONE SPECIFIED BY MANUFACTURER.	Med Cond Aggravated By Exp: CONTRAINDICATED FOR PATIENTS W/KNOWN SEIZURE DISORDERS.	Med Cond Aggravated By Exp: CONVULSIVE DISORDERS, SENSITIVITY TO LINDANE, SKIN RASH.

Ingredients/Identity Information
=========================================================
Proprietary: NO
Ingredient: LINDANE (HEXACHLOROCYCLOHEXANE,GAMMA ISOMER) (SARA III)
Ingredient Sequence Number: 01
Percent: 1.
NIOSH (RTECS) Number: GV4900000
CAS Number: 58-89-9
OSHA PEL: S, 0.5 MG/M3
ACGIH TLV: S, 0.5 MG/M3; 9192
-------------------------------------
Proprietary: NO
Ingredient: POLYOXYETHYLENE SORBITAN MONOSTEARATE (CAS.NO.90-05-67-8)
Ingredient Sequence Number: 02
Percent: UNK
NIOSH (RTECS) Number: WG2934000
CAS Number: 9005-67-8
-------------------------------------
Proprietary: NO
Ingredient: TRIETHANOLAMINE LAURYL SULFATE
Ingredient Sequence Number: 03
Percent: UNK
NIOSH (RTECS) Number: WT1000000
CAS Number: 139-96-8
-------------------------------------
Proprietary: NO
Ingredient: ACETONE (SARA III)
Ingredient Sequence Number: 04
Percent: UNK
NIOSH (RTECS) Number: AL3150000
CAS Number: 67-64-1
OSHA PEL: 1000PPM
ACGIH TLV: 750PPM/1000STEL;9293
-------------------------------------
Proprietary: NO
Ingredient: WATER,PURIFIED
Ingredient Sequence Number: 05
NIOSH (RTECS) Number: ZC0110000
CAS Number: 7732-18-5
=======================================================
Physical/Chemical Characteristics
=======================================================
Appearance And Odor: PEARL WHITE CREAM WITH FLORAL ODOR.
Boiling Point: UNKNOWN
Melting Point: UNKNOWN
Vapor Pressure (MM Hg/70 F): UNKNOWN
Vapor Density (Air=1): UNKNOWN
Specific Gravity: .95-1.05
Decomposition Temperature: UNKNOWN
Evaporation Rate And Ref: UNKNOWN
Solubility In Water: DISPERSABLE pH: 8-9
Corrosion Rate (IPY): UNKNOWN

REED & CARNRICK PHARMACEUTICALS DIV OF BLOCK -- KWELL CREAM - LINDANE CREAM,USP MATERIAL SAFETY DATA SHEET

Precautions for Safe Handling and Use =======================================================
Steps If Matl Released/Spill: WIPE UP SPILLS WITH ADSORBENT MATERIAL AND PLACE IN AN APPROPRIATE DISPOSAL CONTAINER.
Neutralizing Agent: NOT APPLICABLE
Waste Disposal Method: DISPOSE OF IN ACCORDANCE WITH ALL APPLICABLE FEDERAL, STATE,AND LOCAL REGULATIONS. MANUFACTURER STATES THAT THIS PRODUCT CAN BE DISPOSED OF IN THE TRASH.
Precautions-Handling/Storing:
STORE IN TIGHTLY CLOSED CONTAINER AT ROOM TEMPERATURE (59-86C).
AVOID CONTACT WITH SKIN AND EYES.
Other Precautions: NONE

BARRE-NATIONAL -- LINDANE USP 1% LOTION - LINDANE LOTION, USP MATERIAL SAFETY DATA SHEET

Precautions for Safe Handling and Use =======================================================
Steps If Matl Released/Spill: SCOOP UP AND PLACE IN CLOSED CONTAINER FOR PROPER DISPOSAL.
Neutralizing Agent: NONE SPECIFIED BY MANUFACTURER.
Waste Disposal Method: DISPOSE OF IN ACCORDANCE WITH LOCAL, STATE AND FEDERAL ENVIRONMENTAL REGULATIONS. Precautions-Handling/Storing: STORE IN A COOL, DRY PLACE.
Other Precautions: NONE SPECIFIED BY MANUFACTURER.

MSDS
Safety Card --LINDANE 58-89-9 GV4900000
BARRE-NATIONAL -- LINDANE USP 1% LOTION - LINDANE LOTION, USP
BARRE-NATIONAL -- LINDANE USP 1% SHAMPOO
CHEM SERVICE -- LINDANE (BHC GAMMA ISOMER), F104
DRAGON -- 4908-4916 DRAGON LINDANE BORER SPRAY
NATIONAL PHARMACEUTICAL MFG DIV BARRE-NATIONA -- LINDANE SHAMPOO USP, 1% - LINDANE SHAMPOO USP
OCTAGON PROCESS -- MIL-I-11490E,INSECTIDE,LINDANE 1% DUST - INSECTIDE, LINDANE POWDER
REED & CARNRICK DIV OF BLOCK DRUG -- KWELL CREAM - LINDANE CREAM,USP
REED & CARNRICK PHARMACEUTICALS DIV OF BLOCK -- KWELL CREAM - LINDANE CREAM,USP
REED & CARNRICK PHARMACEUTICALS DIV OF BLOCK -- KWELL LOTION - LINDANE LOTION,USP
REED & CARNRICK PHARMACEUTICALS DIV OF BLOCK -- KWELL SHAMPOO - LINDANE SHAMPOO,USP
SOUTHERN MILL CREEK PRODUCTS -- LINDANE 25WP

Toxicology Reports:
Lindane
Lindane
beta-Lindane
alpha-Lindane
delta-Lindane
Spritzlindane
gamma-Lindane
Kilex lindane
Lindane-solvent mixtures
2-Pivaloylindane-1,3-dione
2-Phenyl-2-morpholinomethylindane-1,3-dione
5-Acetyl-3-isopropyl-1,1,2,6-tetramethylindane
trans-1-(2-Dimethylaminoethoxy)-2-benzylindane hydrochloride
trans-1-(2-Piperidinoethoxy)-2-benzylindane hydrogen oxalate
1-(N-Methyl-4-piperylidene)-2,2-dimethylindane hydrochloride
1-(N-Methyl-4-piperylidene)-2,2-dimethylindane hydrochloride
trans-1-(3-(4-Methylpiperazino)propoxy)-2-benzylindane dioxalate
2-(4-Bis(2-chloroethyl)aminophenyl)-2-hydroxymethylindane-1,3-dione

April 3, 1996

FDA REQUIRES LABELING CHANGE ON
LINDANE-CONTAINING LICE TREATMENTS

FDA has recently received inquiries about its recent decision to require manufacturers of certain scabies and lice treatments to caution consumers about the active ingredient, lindane (gamma benzene hexachloride). The following can be used to answer questions:

FDA investigated claims that lindane, an insecticide used in prescription-only treatments for both lice and scabies, caused neurological damage in children. FDA scientists reviewed the available data on this issue and determined that lindane is, in fact, generally safe and effective when used according to the approved directions, but that its overuse can be harmful. FDA's Dermatologic Drugs Advisory Committee previously examined this issue and made the same determination of safety and efficacy of lindane.

The reasons for the products' misuse may be connected with pruritus -- itching that continues after successful treatment -- due to the residual inflammation in the skin. When the treated children continue to scratch, some parents may continue to medicate beyond the recommended procedure.

In other cases, parents may be inclined to overuse the product in their zeal to treat children as quickly as possible. This increases the amount of lindane to which children are exposed and raises the likelihood for adverse reactions to occur.

Other scabies and lice treatments that do not contain lindane are available to consumers. FDA has recommended labeling changes that encourage lindane's use only for patients who have either failed to respond to adequate doses, or are intolerant of, other approved therapies.

Additionally, lindane products' labeling will advise health care providers and parents not to confuse prolonged itching with reinfestation. They should carefully consider when further applications are needed. The drug's label already warns parents that neurotoxicity, damage to nerves or nerve tissue, is a possibility among certain patients, especially infants.

FDA MEDWATCH