Capsaicin Cream 0.1%

Capsaicin Cream 0.1%
SPL v4
SPL
SPL Set ID ef5bb0fa-afc2-62d7-e053-2a95a90a37f4
Route
TOPICAL
Published
Effective Date 2020-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.1 g)
Inactive Ingredients
Cetyl Alcohol Aloe Vera Leaf Xanthan Gum Mineral Oil Stearyl Alcohol Water Petrolatum Glyceryl Stearate Se Propylene Glycol Peppermint Oil Glyceryl Stearate/peg-100 Stearate Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-08

Description

Capsaicin 0.1%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.1%

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • sprains
Warnings

For external use only: Read all warnings and directions before use. Test first on small area of skin.

Do not use:

  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • do not use with heating pad or expose area to sunlight

When using this product:

  • you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
  • avoid contact with the eyes, lips, nose and mucous membranes
  • do not tightly wrap or bandage the treatment area
  • do not apply heat to the treated area immediately before or after use
Packaging

Questions

Questions? Comments?

1-855-361-3993

Manufactured for:

AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

Directions

Adults and Children 18 years of age and older:

  • apply a thin film of cream to affected area and gently rub in until fully absorbed
  • unless treating hands, wash hands thoroughly with soap and water immediately after application
  • for best results, apply 3 to 4 times daily

Children under 18 years:

Ask a doctor

Active Ingredient

Capsaicin 0.1%

Other Information

Store at room temperature 15°-30°F (59°-86°F)

Inactive Ingredients

Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Stop Use and Ask Doctor

Stope Use and Ask Doctor if:

  • Condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs
Keep Out of the Reach of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • sprains
Purpose

Topical Analgesic

Warnings

For external use only: Read all warnings and directions before use. Test first on small area of skin.

Do not use:

  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • do not use with heating pad or expose area to sunlight

When using this product:

  • you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
  • avoid contact with the eyes, lips, nose and mucous membranes
  • do not tightly wrap or bandage the treatment area
  • do not apply heat to the treated area immediately before or after use
Packaging

Questions

Questions? Comments?

1-855-361-3993

Manufactured for:

AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

Directions

Adults and Children 18 years of age and older:

  • apply a thin film of cream to affected area and gently rub in until fully absorbed
  • unless treating hands, wash hands thoroughly with soap and water immediately after application
  • for best results, apply 3 to 4 times daily

Children under 18 years:

Ask a doctor

Active Ingredient

Capsaicin 0.1%

Other Information

Store at room temperature 15°-30°F (59°-86°F)

Inactive Ingredients

Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Stop Use and Ask Doctor

Stope Use and Ask Doctor if:

  • Condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs
Keep Out of the Reach of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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