AQUACOOL RED 500- menthol gel

AQUACOOL RED 500 by

Drug Labeling and Warnings

AQUACOOL RED 500 by is a Otc medication manufactured, distributed, or labeled by Pharmanuco. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHOL

INACTIVE INGREDIENT

WATER, GLYCERIN, CABORBER, ACETYL GLUCOSAMINE, IPA, CAMPHOR, METHILPARABEN, KONIO NP-12, RHEODOL O120, EUCALYPTUS OIL, VANILLYL BUTYL ETER, SF1202, LEMON SCENTED TEA TREE OIL, RED102, SODIUM HYDROXIDE, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, LEPTOSPERMUM PETERSONII OIL, ARNICA MONTANA FLOWER EXTRACT

PURPOSE

To relieve pain

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Apply proper amount to desired area(s) and massage the applied area until it's absorbed to the skin thoroughly.

DOSAGE & ADMINISTRATION

for external use only

WARNINGS

1. Under normal room conditions, the shelf life is estimated at 2 years.
2. Recommended Use: Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, sprains.
3. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
4. Rub in thoroughly until gel is absorbed.
5. Use with caution on sensitive areas.
6. It is recommended that you do a patch test before applying liberally to the skin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AQUACOOL RED 500 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70759-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70759-0007-1	120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2016	05/02/2016
2	NDC: 70759-0007-2	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/02/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/04/2016

Labeler - Pharmanuco (687825097)

Registrant - Pharmanuco (687825097)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmanuco		687825097	manufacture(70759-0007)