SPL v2
SPL
SPL Set ID 43e00e17-1a48-43db-9589-834568917bbf
Route
TOPICAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Ricinus Communis (castor) Seed Oil Beeswax Helianthus Annuus (sunflower) Seed Oil Prunus Amygdalus Dulcis (sweet Almond) Oil Theobroma Cacao (cocoa) Seed Butter Butyrospermum Parkii (shea) Butter Simmondsia Chinensis (jojoba) Seed Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Drug Facts

Purpose

Anti-itch, Topical Analgesic


Medication Information

Purpose

Anti-itch, Topical Analgesic

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Warnings:
  • for external use only
  • Avoid contact with eyes  
Directions:
  • Adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: consult a physician
Indications:

Helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin and lips and offers temporary relief of minor skinirritations and inflammation due to 

  • Weather
  • Allergies
  • Cold sores
  • Eczema
  • Cosmetics

Other uses of this product should only be under the advice or supervision of a doctor.

Active Ingredients

Hydrocortisone 1%

Inactive Ingredients:

• Ricinus Communis (Castor) Seed Oil • Beeswax • Helianthus Annuus (Sunflower) Seed Oil • Prunus Amygdalus Dulcis (Sweet Almond) Oil

• Theobroma Cacao (Cocoa) Seed Butter • Butyrospermum Parkii (Shea) Butter • Simmondsia Chinensis (Jojoba) Seed Oil

• Tocopheryl Acetate

Questions Or Comments:
Principal Display Panel

For External Anal Itching:
  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Stop Use and Ask A Physician:
  • if condition worsens or symptoms persist for 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a physician

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Anti-itch, Topical Analgesic

Warnings:
  • for external use only
  • Avoid contact with eyes  
Directions:
  • Adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: consult a physician
Indications:

Helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin and lips and offers temporary relief of minor skinirritations and inflammation due to 

  • Weather
  • Allergies
  • Cold sores
  • Eczema
  • Cosmetics

Other uses of this product should only be under the advice or supervision of a doctor.

Active Ingredients (Active ingredients)

Hydrocortisone 1%

Inactive Ingredients: (Inactive ingredients:)

• Ricinus Communis (Castor) Seed Oil • Beeswax • Helianthus Annuus (Sunflower) Seed Oil • Prunus Amygdalus Dulcis (Sweet Almond) Oil

• Theobroma Cacao (Cocoa) Seed Butter • Butyrospermum Parkii (Shea) Butter • Simmondsia Chinensis (Jojoba) Seed Oil

• Tocopheryl Acetate

Questions Or Comments: (Questions or Comments:)
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

For External Anal Itching: (For external anal itching:)
  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Stop Use and Ask A Physician: (Stop use and ask a physician:)
  • if condition worsens or symptoms persist for 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a physician

Advanced Ingredient Data


Raw Label Data

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