Drug Facts

Drug Facts
SPL v13
SPL
SPL Set ID 2670c9c4-66ad-40e8-a08a-582b160de39d
Route
TOPICAL
Published
Effective Date 2017-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Ceteth-20 Mineral Oil Petrolatum Cetostearyl Alcohol Edetate Sodium Propylene Glycol Water Sodium Metabisulfite Chlorocresol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-02-05

Description

Hydrocortisone Acetate, USP (1% w/w)

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)



Description

Hydrocortisone Acetate, USP (1% w/w)

Uses

For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external gential, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.



Warnings

FOR EXTERNAL USE ONLY.

Directions
  • Adults and children over 2 years of age
  • Apply evenly to affected area no more than 3 to 4 times daily
  • Children under 2 years of age
  • Do not use, consult a doctor
  • Adults- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry, patting or blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area up to 6 times daily or after bowel movment
  • After application, discard pad. Do not flush in toilet.
Do Not Use
  • In the eyes
  • for diaper rash
  • if you have vaginal discharge
  • more than recommended dosage.
Other Information
  • Store at 20 o-25 oC(68 o-77 oF)
  • Avoid excessive heat and humidity.
Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Chloracresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.

Principal Display Panel

Ask A Doctor Before Use If

you are pregnant or breast feeding

Active Ingredient (per Gram)

Hydrocortisone Acetate, USP (1% w/w)

Stop Use and Ask A Doctor If
  • the condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days.
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external gential, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.



Purpose

Antipruritic (Anti-Itch)



Warnings

FOR EXTERNAL USE ONLY.

Directions
  • Adults and children over 2 years of age
  • Apply evenly to affected area no more than 3 to 4 times daily
  • Children under 2 years of age
  • Do not use, consult a doctor
  • Adults- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry, patting or blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area up to 6 times daily or after bowel movment
  • After application, discard pad. Do not flush in toilet.
Do Not Use (Do not use)
  • In the eyes
  • for diaper rash
  • if you have vaginal discharge
  • more than recommended dosage.
Other Information
  • Store at 20 o-25 oC(68 o-77 oF)
  • Avoid excessive heat and humidity.
Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Chloracresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.

Principal Display Panel

Ask A Doctor Before Use If (Ask a doctor before use if)

you are pregnant or breast feeding

Active Ingredient (per Gram) (Active Ingredient (per gram))

Hydrocortisone Acetate, USP (1% w/w)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days.
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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