Kapsin External Analgesic: Package Insert and Label Information

KAPSIN EXTERNAL ANALGESIC- camphor (natural) and capsaicin ointment
Bee Right 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.

Drug Facts

Active Ingredient

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, 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, capsicum frutescens fruit extract, lanolin wax, petrolatum, propolis wax, waterright away.

Package Labeling:

Outer Package2
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Inner Package2
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KAPSIN EXTERNAL ANALGESIC
camphor, capsaicin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71952-020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 3.16 g in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.03 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
PETROLATUM
PROPOLIS WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71952-020-00 1 TUBE in 1 BOX contains a TUBE
1 60 g in 1 TUBE This package is contained within the BOX (71952-020-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/01/2018
Labeler — Bee Right LLC (080988303)

Revised: 07/2018 Bee Right LLC

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