THERAPEUTIC ICE- menthol 2.00% gel

Therapeutic Ice by

Drug Labeling and Warnings

Therapeutic Ice by is a Otc medication manufactured, distributed, or labeled by TopCare, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                    Purpose
Menthol 2%...........................................External Analgesic

PURPOSE

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains
of muscles and joints associated with simple backache,
arthritis, strains, bruises and sprains

WARNINGS

Warnings
For external use only
When using this product avoid
contact with eyes do not bandage tightly do not apply to
wounds or damaged skin do not use with a heating pad
Stop use and ask doctor if condition worsens or if
symptoms persist for more than 7 days or clear up and
occur again within a few days
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Directions
for adults & children 2 years of age and older
cleanse and dry skin
apply to affected area not more than 3 to 4 times daily
children under 2 years of age, consult a doctor

INACTIVE INGREDIENT

Inactive ingredients

Ammonium Hydroxide,
Carbomer, Cupric Sulfate, FD&C Blue No. 1, Isopropyl
Alcohol, Magnesium Sulfate, Purified Water, Sodium
Hydroxide, Thymol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERAPEUTIC ICE 
menthol 2.00% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-879
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
Cupric Sulfate (UNII: LRX7AJ16DT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Isopropyl Alcohol (UNII: ND2M416302)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
WATER (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)
Thymol (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-879-06	227 g in 1 JAR; Type 0: Not a Combination Product	03/21/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/21/2012

Labeler - TopCare (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-879) , label(36800-879)