AQUACOOL SHOWER- menthol gel 
Pharmanuco

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.

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Drug Facts

MENTHOL

Alcohol, Camphor, Eucalyptus Globulus Leaf Oil, Leptospermum Petersonii Oil, Fragrance

To relieve pain

keep out of reach of the children


  1. Shake well before use.
  2. Hold can more than 20 cm away from treatment area.
  3. Apply using a sweeping motion.

for external use only


  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.

Label

AQUACOOL SHOWER 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70759-0009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
CAMPHOR, (-)- (UNII: 213N3S8275)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70759-0009-1200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/04/2016
Labeler - Pharmanuco (687825097)
Registrant - Pharmanuco (687825097)
Establishment
NameAddressID/FEIBusiness Operations
Pharmanuco687825097manufacture(70759-0009)

Revised: 3/2021
Document Id: bd28bb54-df2c-440b-e053-2995a90a56a0
Set id: 35fc786c-9b06-697d-e054-00144ff88e88
Version: 2
Effective Time: 20210310
 
Pharmanuco