DR. WALTONS COOL AND HOT ANALGESIC- menthol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

DR. WALTONS, INCORPORATED

INN (International Name):

MENTHOL

Composition:

MENTHOL 2.27 g in 227 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

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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DR. WALTON'S COOL AND HOT ANALGESIC GEL
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 ANALGESIC
menthol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:76 271-0 0 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
2.27 g in 227 g
DR. WALTONS, INCORPORATED
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:76 271-0 0 3-0 8
227 g in 1 JAR
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt346
0 7/14/20 11
LABELER -
DR. WALT ONS, INCORPORAT ED (041377104)
Revised: 6/2011