Drug Facts Elixir Cortirelief

Drug Facts Elixir Cortirelief
SPL v1
SPL
SPL Set ID a6ca66f3-9759-4c98-a758-45700bc08352
Route
TOPICAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Polyethylene Glycol 1000 Cetostearyl Alcohol Chlorocresol Edetate Disodium Mineral Oil Propylene Glycol Water Sodium Metabisulfite Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-31

Description

Hydrocortisone Acetate USP 1% w/w

Purpose

Anti-Itch Cream


Medication Information

Purpose

Anti-Itch Cream

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, jewellery, for external genital, feminine and anal itching

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, Clean 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 upto 6 times daily or after each bowel movement. After application, discard pad. Do not flush in toilet.

Do Not Use

• In the eyes

• For diaper rash

If you have vaginal discharge, more then recommended dosage.

Other Information

Store at 20°-25°C (68°-77°F)

avoid excessive heat and humidity

Inactive Ingredients

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

Principal Display Panel

Reorder No. xxxx

Elixir

Hydrocortisone Cream 1%

Anti-Itch Cream

Net Wt. 1 OZ. (28.3G)

Stop Use and Ask A Doctor If

• the condition worsens or if symptoms persist 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.

Active Ingredient (in Each Gram)

Hydrocortisone Acetate USP 1% w/w

Ask A Doctor Before Use in Case Of

• you are pregnant or breast-feeding


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, jewellery, for external genital, feminine and anal itching

Purpose

Anti-Itch Cream

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, Clean 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 upto 6 times daily or after each bowel movement. 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 then recommended dosage.

Other Information (Other information)

Store at 20°-25°C (68°-77°F)

avoid excessive heat and humidity

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Reorder No. xxxx

Elixir

Hydrocortisone Cream 1%

Anti-Itch Cream

Net Wt. 1 OZ. (28.3G)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• the condition worsens or if symptoms persist 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.

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Hydrocortisone Acetate USP 1% w/w

Ask A Doctor Before Use in Case Of (Ask a doctor before use in case of)

• you are pregnant or breast-feeding


Advanced Ingredient Data


Raw Label Data

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