Capsaicin Cream 0.1%

Capsaicin Cream 0.1%
SPL v4
SPL
SPL Set ID ef5b0db6-8f0a-4f8e-e053-2995a90a22b7
Route
TOPICAL
Published
Effective Date 2020-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.001 g)
Inactive Ingredients
Water Cetyl Alcohol Petrolatum Peppermint Oil Peg-100 Stearate Phenoxyethanol Glyceryl Stearate Se Xanthan Gum Mineral Oil Aloe Vera Leaf Stearyl Alcohol Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-08

Description

Active Ingredient: Capsaicin 0.1%


Medication Information

Warnings and Precautions

Warnings: For external use only.

Do not use:

  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • with heating pad

When using this produce:

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

Stop use and ask a doctor if:

  • condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs
Indications and Usage

Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration

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.

Description

Active Ingredient: Capsaicin 0.1%

Section 42229-5

Questions? Comments?

1-855-361-3993

Manufactured for:

AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

Section 44425-7

Other Information: store at room temperature 15° - 30°C (59° - 86°F)

Section 50565-1

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

Section 51727-6

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

Section 55105-1

Purpose: Topical Analgesic

Section 55106-9

Active Ingredient: Capsaicin 0.1%

Packaging


Structured Label Content

Indications and Usage (34067-9)

Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings: For external use only.

Do not use:

  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • with heating pad

When using this produce:

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

Stop use and ask a doctor if:

  • condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs
Section 42229-5 (42229-5)

Questions? Comments?

1-855-361-3993

Manufactured for:

AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

Section 44425-7 (44425-7)

Other Information: store at room temperature 15° - 30°C (59° - 86°F)

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 55105-1 (55105-1)

Purpose: Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient: Capsaicin 0.1%

Packaging


Advanced Ingredient Data


Raw Label Data

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