KAPSIN- camphor (synthetic), capsaicin ointment 
Apipharmausa, LLC

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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Kapsin

Drug Facts

Active ingredients

Camphor 3.16%

Capsaicin 0.03%

Purpose

External Analgesic

Uses

  • for 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 apply to wounds or damaged skin
  • do not bandage tightly

Stop use and consult a doctor if:

  • condition worsens or if symptoms persist for more than 7 days
  • if conditions 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 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

Other information

  • store at 77°F (25°C)

Inactive ingredients

alcohol, chili pepper (capsicum frutescens) fruit extract, lanolin wax, petrolatum, propolis wax, water.

Package Labeling:

Outer PackageInner Package

KAPSIN 
camphor (synthetic), capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73061-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)31.6 mg  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CAPSICUM (UNII: 00UK7646FG)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73061-003-601 in 1 BOX09/04/2020
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/04/2020
Labeler - Apipharmausa, LLC (117030000)

Revised: 9/2020
Document Id: aed34082-f268-7f3b-e053-2a95a90ac8c1
Set id: 66d5c4ab-5395-4ede-8430-7c9c0e211975
Version: 1
Effective Time: 20200908
 
Apipharmausa, LLC