AQUACOOL RED 500- 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

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

To relieve pain

keep out of reach of the children


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

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 RED 500 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70759-0007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70759-0007-1120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/201605/02/2016
2NDC:70759-0007-2500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/02/2016
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(70759-0007)

Revised: 6/2016
Document Id: 363dbb18-7e84-0255-e054-00144ff8d46c
Set id: 35fbc9b0-e466-5717-e054-00144ff8d46c
Version: 3
Effective Time: 20160627
 
Pharmanuco