DR. WALTON'S COOL AND HOT ANALGESIC GEL

DR. WALTONS COOL AND HOT ANALGESIC - menthol gel
DR. WALTONS, INCORPORATED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MENTHOL: 1.0%

TOPICAL ANALGESIC

DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE

PROVIDES TEMPORARY RELIEF OF MINOR ACHES AND PAINS IN MUSCLES AND JOINTS ASSOCIATED WITH SIMPLE BACKACHE, STRAINS, ARTHRITIS AND SPORTS INJURIES.

FOR EXTERNAL USE ONLY. NOT FOR INTERNAL USES. AVOID CONTACT WITH EYES OR MUCOUS MEMBRANES. DO NOT APPLY TO OPEN WOUNDS OR DAMAGED SKIN. MAKE SURE SKIN IS CLEAN AND FREE FROM CREAMS, OINTMENTS, SPRAYS OR LINIMENT. DO NOT BANDAGE.

CLEAN SKIN OF ALL OTHER LOTIONS, CREAMS, OINTMENTS, LINIMENT OR SPRAYS. APPLY LIBERALLY TO AFFECTED AREA AND MASSAGE UNTIL ABSORBED INTO SKIN. DO NOT APPLY MORE THAN 3-4 TIMES DAILY. NO PROTECTIVE COVER NEEDED.

WATER, ISOPROPYL ALCOHOL, NONOXYNOL-10, CAMPHOR, CARBOMER, SODIUM HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE AND METHYLISOTHIAZONLINONE, BLUE 1 (CI42090)

DR WALTONS COOL AND HOT LABEL

DR. WALTONS COOL AND HOT ANALGESIC
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76271-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.27 g in 227 g

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76271-003-08	227 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	07/14/2011

Labeler - DR. WALTONS, INCORPORATED (041377104)