Capsaicin 0.075% Cream

Capsaicin 0.075% Cream
SPL v1
SPL
SPL Set ID 30911225-a6d7-4b2b-9005-b733373e2877
Route
TOPICAL
Published
Effective Date 2025-06-03
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 Stearate Mineral Oil Peg-100 Stearate Peppermint Oil Petrolatum Phenoxyethanol Propylene Glycol Stearyl Alcohol Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-02

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 42229-5

Questions? Call 877-227-3137

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 55105-1

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 - NDC 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Tube Label

Capsaicin 0.075% Cream - NDC 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Carton Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054


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 42229-5 (42229-5)

Questions? Call 877-227-3137

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 55105-1 (55105-1)

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 - NDC 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Tube Label

Capsaicin 0.075% Cream - NDC 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Carton Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054


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