THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON- menthol gel

THERAPEUTIC ICY COLD by

Drug Labeling and Warnings

THERAPEUTIC ICY COLD by is a Otc medication manufactured, distributed, or labeled by APEX-CAREX HEATHCARE PRODUCTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

NATURAL MENTHOL 3.9%

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

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, APPLY TO 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERAPEUTIC ICY COLD  COOLING PAIN RELIEF ROLL-ON
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69851-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69851-101-13	88.8 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/15/2015

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

Labeler - APEX-CAREX HEATHCARE PRODUCTS (622368947)