AQUACOOL- menthol spray 
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, WATER, GLYCERIN, EUCALYPTUS GLOBULUS LEAF OIL, GLYCYRRHIZA (LICORICE) ROOT EXTRACT, BOSWELLIA SERRATA GUM EXTRACT, ALLANTOIN

To relieve pain

keep out of reach of the children


Spray proper amount to treatment area(s)

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 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70759-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70759-0004-1150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/201608/09/2016
2NDC:70759-0004-2120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/09/2016
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(70759-0004)

Revised: 3/2021
Document Id: bd285802-419b-aa26-e053-2995a90a2ad8
Set id: 35fbc9b0-e46a-5717-e054-00144ff8d46c
Version: 3
Effective Time: 20210309
 
Pharmanuco