MENCYLATE PAIN RELIEVING- menthol, methyl salicylate cream 
PureTek Corporation

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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Mencylate

Active ingredients


Menthol 2.0%
Methyl Salicylate 10.0%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only.

Do not

• apply on wounds or damaged skin • bandage tightly

When using this product

• avoid contact with the eyes or mucous membranes • do not use other than as directed

Stop use and ask a doctor if

• condition worsens • 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

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. • Children under 12 years of age: consult a doctor.

Other information

• Store at controlled room temperature 20°-25°C (68°-77°F).

Inactive ingredients:

Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Borago Officinalis Seed Oil, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, DL-Alpha-Tocopheryl Acetate, Eucalyptus Globulus Leaf Oil, Fragrance, Fructose, Phenoxyethanol, Propylene Glycol, Squalane, Stearic Acid, Stearyl Alcohol, Sodium Hydroxide, Tetrasodium EDTA, Vitis Vinifera (Grape) Seed Oil.

Mencylate TM

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free: 1-877-921-7873 Label

MENCYLATE  PAIN RELIEVING
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
CARBOMER 934 (UNII: Z135WT9208)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FRUCTOSE (UNII: 6YSS42VSEV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-215-0559 mL in 1 JAR; Type 0: Not a Combination Product03/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/24/2023
Labeler - PureTek Corporation (785961046)

Revised: 3/2023
Document Id: f824de86-9491-2e6b-e053-6294a90a6f2a
Set id: f824de86-9492-2e6b-e053-6294a90a6f2a
Version: 1
Effective Time: 20230324
 
PureTek Corporation