THERAPEUTIC ICY COLD COOLING PAIN RELIEF- menthol gel
APEX-CAREX HEATHCARE PRODUCTS

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.

----------

ACTIVE INGREDIENT

NATURAL MENTHOL 6%

PURPOSE

COOLING PAIN RELIEF

USES

TEMPORARY RELIEF OF

ARTHRITIS
BACKACHE
STRAINS
SPRAINS

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.

DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGES.

DO NOT USE IF PREGNANT OR BREASTFEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.

DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

KEEP OUT OF REACH OF CHILDREN.

IF ACCIDENTALLY INGESTED, SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER, SPRAY ONTO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.
RUB IN THOROUGHLY UNTIL GEL IS ABSORBED.

INACTIVE INGREDIENTS

WATER, SD ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT (YERBA MATE), HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT (CAT'S CLAW), BOSWELIA SERRATA EXTRACT, CAMPHOR FOR SCENT

ICY COLD Cooling Pain Relief_Topical Gel

THERAPEUTIC ICY COLD COOLING PAIN RELIEF
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69851-104
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.9 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
UNCARIA TOMENTOSA LEAF (UNII: 487U8M3D2P)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
CAMPHOR OIL (UNII: 75IZZ8Y727)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69851-104-14	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/15/2015	05/31/2015

Labeler - APEX-CAREX HEATHCARE PRODUCTS (622368947)

Revised: 6/2015

Document Id: f05843ed-6a56-4526-9fe6-270e3f97f67e

Set id: 30c16093-e6bd-4de5-a91d-7281b1c4733d

Version: 2

Effective Time: 20150601

APEX-CAREX HEATHCARE PRODUCTS