Capsaicin 0.075% Cream

Capsaicin 0.075% Cream
SPL v2
SPL
SPL Set ID 33e861bd-bb92-4aea-9d4d-1b8847c794fd
Route
TOPICAL
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.075 g)
Inactive Ingredients
Aloe Vera Leaf Juice Cetyl Alcohol Glyceryl Monostearate Mineral Oil Peg-100 Monostearate Peppermint Oil Petrolatum Phenoxyethanol Propylene Glycol Stearyl Alcohol Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-12

Description

Capsaicin 0.075%.............................................Topical Analgesic


Medication Information

Dosage and Administration

Directions adults and children 18 years and older:

  • apply a thin film of cream to the 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

Capsaicin 0.075%.............................................Topical Analgesic

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Section 50565-1

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

Section 50569-3

Section 53413-1

Questions?Call

Warnings

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

Do not use

  • on wounds or damaged skin
  • if you are allergic to capsaicum or chili peppers

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 use and ask doctor if

  • condition worsens or does not improve after regular use
  • severe burning persists or blistering occurs
Drug Facts

Capsaicin 0.075%.............................................Topical Analgesic

Other Information

Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.

Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, glyceryl stearate, mineral oil, PEG-100 stearate, peppermint oil, petrolatum, phenoxyethanol, propylene glycol, stearyl alcohol, water, xanthan gum

Principal Display Panel

Capsaicin 0.075% Cream

Pain Relieving Cream

Topical Analgesic

2.11 oz (60g)


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Dosage and Administration (34068-7)

Directions adults and children 18 years and older:

  • apply a thin film of cream to the 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

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

Section 53413-1 (53413-1)

Questions?Call

Warnings

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

Do not use

  • on wounds or damaged skin
  • if you are allergic to capsaicum or chili peppers

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 use and ask doctor if

  • condition worsens or does not improve after regular use
  • severe burning persists or blistering occurs
Drug Facts (Drug facts)

Capsaicin 0.075%.............................................Topical Analgesic

Other Information (Other information)

Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.

Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, glyceryl stearate, mineral oil, PEG-100 stearate, peppermint oil, petrolatum, phenoxyethanol, propylene glycol, stearyl alcohol, water, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Capsaicin 0.075% Cream

Pain Relieving Cream

Topical Analgesic

2.11 oz (60g)


Advanced Ingredient Data


Raw Label Data

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