THERAPEUTIC MENTHOL- menthol 2.00% gel 
Product Quest Mfg

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

Active ingredient                                    Purpose
Menthol 2%...........................................External Analgesic

Uses

For the temporary relief of minor aches and pains
of muscles and joints associated with simple backache,
arthritis, strains, bruises and sprains

Warnings
For external use only
When using this product • avoid
contact with eyes • do not bandage tightly • do not apply to
wounds or damaged skin • do not use with a heating pad
Stop use and ask doctor if condition worsens or if
symptoms persist for more than 7 days or clear up and
occur again within a few days
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away

Directions
• for adults & children 2 years of age and older
• cleanse and dry skin
• apply to affected area not more than 3 to 4 times daily
• children under 2 years of age, consult a doctor

Inactive ingredients

Ammonium Hydroxide,
Carbomer, Cupric Sulfate, FD&C Blue No. 1, Isopropyl
Alcohol, Magnesium Sulfate, Purified Water, Sodium
Hydroxide, Thymol.

Questions? 866-483-2846

image description

THERAPEUTIC MENTHOL 
menthol 2.00% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-5117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
Cupric Sulfate (UNII: LRX7AJ16DT)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Isopropyl Alcohol (UNII: ND2M416302)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
WATER (UNII: 059QF0KO0R)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Thymol (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-5117-7227 g in 1 JAR; Type 0: Not a Combination Product03/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/24/2017
Labeler - Product Quest Mfg (927768135)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(64048-5117) , label(64048-5117)

Revised: 8/2018
Document Id: 84801e26-b6e9-47d8-928c-05302ef4ce5f
Set id: bf5a1281-7044-4c0e-97f5-331886ae92e8
Version: 1
Effective Time: 20180807
 
Product Quest Mfg