Label: AQUACOOL SHOWER- menthol gel
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 10, 2021
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- Under normal room conditions, the shelf life is estimated at 2 years.
- Recommended Use: Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, sprains.
- 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.
- Use with caution on sensitive areas.
- It is recommended that you do a patch test before applying liberally to the skin.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70759-0009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) CAMPHOR, (-)- (UNII: 213N3S8275) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70759-0009-1 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2016 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(70759-0009)