SPL v1
SPL
SPL Set ID 35073eae-26fe-2bb5-e063-6294a90ab56a
Route
TOPICAL
Published
Effective Date 2025-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.1 g)
Inactive Ingredients
Ceteareth-20 Cetostearyl Alcohol Chlorocresol Edetate Sodium Mineral Oil Propylene Glycol Sodium Metabisulfite Water White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-13

Description

Hydrocortisone Acetate 1%

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone Acetate 1%

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • Eczema
  • insect bites
  • poison oak
  • poison sumac
  • detergents
  • cosmetics
  • jewelry
  • seborrheic
  • dermatitis
  • psoriasis
  • for external genital
  • feminine
  • anal itching
Warnings

For external use only

Questions
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 of age: consult a doctor
  • when used for anal itching cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, painting or blotting with bathroom tissue or soft cloth before applying.
Do Not Use
  • in the eyes
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommend daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any other mechanical device or applicator
  • if the seal is torn or if the tube is damaged
Other Information
  • Store at 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium metabisulfite, Water, White Petrolatum

Unclassified Section

Distributed by: SIonBrands LLC

16950 Via de Santa Fe, Rancho Santa Fe, CA, 92067

Mail Address: PO Box 450638, Laredo, TX, 78045

Email: [email protected]

Made in India

Principal Display Panel

NDC 68786-001-28

SIONBIOTEXT

Hydrocortisone Cream 1%

Relief of Minor Skin Irritiation Itching and Rashes

For Personal and Professional Use

Net Wt: 1.0 oz (28.3g)

If Pregnant Or Breastfeeding

ask a health professional before use

Stop Use and Ask A Doctor If
  • condition worsens, or if symptoms persists for more than 7 days or clears up and occurs again within a few days,and do not use this or any other hydrocortisone product
  • in case of bleeding when used for anal itching
Keep Out of Reach of Children

If swallowed get medical help or contact a Posion Control Center right away

Active Ingredient (in Each Gram)

Hydrocortisone Acetate 1%


Structured Label Content

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • Eczema
  • insect bites
  • poison oak
  • poison sumac
  • detergents
  • cosmetics
  • jewelry
  • seborrheic
  • dermatitis
  • psoriasis
  • for external genital
  • feminine
  • anal itching
Purpose

Antipruritic (Anti-Itch)

Warnings

For external use only

Questions
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 of age: consult a doctor
  • when used for anal itching cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, painting or blotting with bathroom tissue or soft cloth before applying.
Do Not Use (Do not use)
  • in the eyes
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommend daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any other mechanical device or applicator
  • if the seal is torn or if the tube is damaged
Other Information
  • Store at 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium metabisulfite, Water, White Petrolatum

Unclassified Section

Distributed by: SIonBrands LLC

16950 Via de Santa Fe, Rancho Santa Fe, CA, 92067

Mail Address: PO Box 450638, Laredo, TX, 78045

Email: [email protected]

Made in India

Principal Display Panel

NDC 68786-001-28

SIONBIOTEXT

Hydrocortisone Cream 1%

Relief of Minor Skin Irritiation Itching and Rashes

For Personal and Professional Use

Net Wt: 1.0 oz (28.3g)

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persists for more than 7 days or clears up and occurs again within a few days,and do not use this or any other hydrocortisone product
  • in case of bleeding when used for anal itching
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed get medical help or contact a Posion Control Center right away

Active Ingredient (in Each Gram) (Active Ingredient (In Each Gram))

Hydrocortisone Acetate 1%


Advanced Ingredient Data


Raw Label Data

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