CAPASIL 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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Capasil

Active ingredients


Menthol 2.0%………... Topical Analgesic
Methyl Salicylate 10%…Topical Analgesic

Purpose

Topical Analgesic

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

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

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

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.

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

Label

Label

CAPASIL  PAIN RELIEVING
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-434
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
MENHADEN OIL (UNII: 1D8HWC57D0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
PALMITIC ACID (UNII: 2V16EO95H1)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-434-0559 mL in 1 JAR; Type 0: Not a Combination Product10/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/14/2020
Labeler - PureTek Corporation (785961046)

Revised: 10/2020
Document Id: b1a8e78c-57f0-1f3e-e053-2995a90acbd5
Set id: b1a8e78c-57f0-1f3e-e053-2995a90acbd5
Version: 1
Effective Time: 20201014
 
PureTek Corporation