Capsaicin Cream 0.075%

Capsaicin Cream 0.075%
SPL v5
SPL
SPL Set ID ef597423-cd01-7324-e053-2a95a90aa1ba
Route
TOPICAL
Published
Effective Date 2022-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.75 mg)
Inactive Ingredients
Peppermint Oil Mineral Oil Aloe Vera Leaf Stearyl Alcohol Xanthan Gum Glyceryl Stearate Se Phenoxyethanol Cetyl Alcohol Peg-100 Stearate Petrolatum Water Propylene Glycol

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

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

Warnings

For external use only

Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.

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

Do Not Use
  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • with heating pad
Active Ingredient

Capsaicin 0.075%

Other Information

Store at room temperature 15° - 30°C (59°F – 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

Questions Or Comments?

1-855-361-3993

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 eyes, lips, nose and mucous membranes
  • do not tightly wrap or bandage the treated area
  • do not apply heat to the treated area immediately before or after use
Stop and Ask A Doctor If
  • condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs
Principal Display Panel 57 G Tube Carton


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Topical Analgesic

Warnings

For external use only

Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.

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

Do Not Use (Do not use)
  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • with heating pad
Active Ingredient (Active ingredient)

Capsaicin 0.075%

Other Information (Other information)

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

Inactive Ingredients (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

Questions Or Comments? (Questions or comments?)

1-855-361-3993

When Using This Product (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 eyes, lips, nose and mucous membranes
  • do not tightly wrap or bandage the treated area
  • do not apply heat to the treated area immediately before or after use
Stop and Ask A Doctor If (Stop and ask a doctor if)
  • condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs
Principal Display Panel 57 G Tube Carton (PRINCIPAL DISPLAY PANEL - 57 g Tube Carton)


Advanced Ingredient Data


Raw Label Data

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