SPL v5
SPL
SPL Set ID 4867eac4-00ea-434e-b289-1c1ef0342c23
Route
TOPICAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Benzyl Alcohol Cetyl Alcohol Anhydrous Citric Acid Glyceryl Stearate/peg-100 Stearate Isopropyl Myristate Petrolatum Water Sorbitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

Description

Capsaicin  0.025%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin  0.025%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backaches, strains, sprains and bruises

Section 51945-4

Warnings

Warnings

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

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 or mucous membranes.  
  • Do no apply immediately before or after activites such as bathing, swimming or sunbathing
  • Do not banage tightly
  • Do no apply heat to the treated area immediately before or after use
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin
  • Do ot expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if:

  • Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
  • Severe burning persists, swelling or blistering occurs
  • Difficulty breathing or swallowing occurs

If pregnant or breast feeding,ask a health professional before use.

Directions

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 hand thoroughly with soap and water immediately after application
  • For best results, apply 3 to 4 times daily

Children under 18 years of age:ask a doctor

Active Ingredient

Capsaicin  0.025%

Inactive Ingredients

Anhydrous Citric Acid, Benzyl Alcohol, Cetyl Alcohol, Glyceryl Stearate/PEG-100 Stearate, Isopropyl Myristate, Petrolatum, Purified Water, Sorbitol

Keep Out of Reach of Children

Keep out of Reach of Children.  If swallowed, get medical helpor contact a Posion Control Center immediately.


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backaches, strains, sprains and bruises

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Warnings

Warnings

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

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 or mucous membranes.  
  • Do no apply immediately before or after activites such as bathing, swimming or sunbathing
  • Do not banage tightly
  • Do no apply heat to the treated area immediately before or after use
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin
  • Do ot expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if:

  • Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
  • Severe burning persists, swelling or blistering occurs
  • Difficulty breathing or swallowing occurs

If pregnant or breast feeding,ask a health professional before use.

Directions

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 hand thoroughly with soap and water immediately after application
  • For best results, apply 3 to 4 times daily

Children under 18 years of age:ask a doctor

Active Ingredient

Capsaicin  0.025%

Inactive Ingredients

Anhydrous Citric Acid, Benzyl Alcohol, Cetyl Alcohol, Glyceryl Stearate/PEG-100 Stearate, Isopropyl Myristate, Petrolatum, Purified Water, Sorbitol

Keep Out of Reach of Children (Keep out of Reach of Children)

Keep out of Reach of Children.  If swallowed, get medical helpor contact a Posion Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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