Capsaicin Cream 0,025%

Capsaicin Cream 0,025%
SPL v4
SPL
SPL Set ID ef5a3846-1d2f-7023-e053-2a95a90ad716
Route
TOPICAL
Published
Effective Date 2021-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.25 mg)
Inactive Ingredients
Glyceryl Stearate Se Cetyl Alcohol Phenoxyethanol Glyceryl Stearate/peg-100 Stearate Petrolatum Stearyl Alcohol Xanthan Gum Peppermint Oil Aloe Vera Leaf Mineral Oil Propylene Glycol Water

Identifiers & Packaging

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

Description

Drug Facts

Purpose

External analgesic


Medication Information

Purpose

External 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.

Section 50570-1

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
  • with heating pad
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 0.025%

Other Information

store at room temperature 15° - 30°C (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

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 the 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 Use and Ask A Doctor If
  • condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs
Principal Display Panel 60 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.

Section 50570-1 (50570-1)

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
  • with heating pad
Purpose

External analgesic

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 (Active ingredient)

Capsaicin 0.025%

Other Information (Other information)

store at room temperature 15° - 30°C (59° - 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 the 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 Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs
Principal Display Panel 60 G Tube Carton (PRINCIPAL DISPLAY PANEL - 60 g Tube Carton)


Advanced Ingredient Data


Raw Label Data

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