ICY COLD COOL PAIN RELIEVING- menthol, camphor gel

ICY COLD COOL PAIN RELIEVING by

Drug Labeling and Warnings

ICY COLD COOL PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by COMPASS HEALTH BRANDS CORP., DIVERSIFIED MANUFACTURING CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

MENTHOL 3.9%

CAMPHOR 0.4%

PURPOSE

TOPICAL ANALGESIC

COUNTER IRRITANT

USES

temporary relief of

• Arthritis
• Backache
• Strains/Sprains

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

Do not use near eyes, mouth, mucus membranes, genitals, 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

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, Isopropyl Alcohol, Propylene Glycol, Glycerin, Carbomer, Ilex Paraguariensis Leaf Extract, Hydrated Silica, Aminomethyl Propanol, Methyl Paraben, Uncaria Tomentosa Extract, Boswelia Serrata Extract, Camphor for scent.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ICY COLD COOL PAIN RELIEVING 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71323-101
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
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
SILICON (UNII: Z4152N8IUI)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
UNCARIA TOMENTOSA WHOLE (UNII: U6P1SV66LA)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71323-101-26	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2017
2	NDC: 71323-101-91	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/22/2017
3	NDC: 71323-101-13	88.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2017
4	NDC: 71323-101-14	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2017
5	NDC: 71323-101-05	5 mL in 1 POUCH; Type 0: Not a Combination Product	03/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/22/2017

Labeler - COMPASS HEALTH BRANDS CORP. (827221698)

Establishment
Name	Address	ID/FEI	Business Operations
DIVERSIFIED MANUFACTURING CORP		185073996	manufacture(71323-101)