DR. WALTONS COOL AND HOT ANALGESIC- menthol gel

DR. WALTONS COOL AND HOT ANALGESIC by

Drug Labeling and Warnings

DR. WALTONS COOL AND HOT ANALGESIC by is a Otc medication manufactured, distributed, or labeled by DR. WALTONS, INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHOL: 1.0%

PURPOSE

TOPICAL ANALGESIC

KEEP OUT OF REACH OF CHILDREN

DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

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

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

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

Labeler - DR. WALTONS, INCORPORATED (041377104)