1137 Hydrocortisone 1% Cream Ndc 67777-004-04

1137 Hydrocortisone 1% Cream Ndc 67777-004-04
SPL v6
SPL
SPL Set ID 81dff9df-6f7e-49f0-e053-2a91aa0af7e7
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Propylene Glycol Methylchloroisothiazolinone White Petrolatum Stearic Acid Trolamine Glyceryl Stearate Se Water Cetostearyl Alcohol

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-25

Description

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone USP 1%

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.

Label

Warnings

For External Use Only

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 doctor.
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth before applying.
  • Children under 12: Consult a doctor before using for anal itching.
Do Not Use
  • In the eyes
  • For diaper rash
  • For external genital or feminine itching if you have a vaginal discharge
  • More than the recommended daily dosage unless directed by a doctor
  • In the rectum by using fingers or any mechanical device or applicator
Label 1137 25

1137-25

Label 1137ub 6

1137UB-6

Other Information
  • Store at room temperature 15º-30ºC (59º-86ºF)
  • Avoid excessive heat
  • Tamper Evident. Do not use if seal is damaged.
Active Ingredients

Hydrocortisone USP 1%

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Petrolateum

Stop Use and Ask A Doctor If
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days)
  • Bleeding occurs due to anal itching
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

Ask a health professional before use


Structured Label Content

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.

Label

Purpose

Antipruritic (Anti-Itch)

Warnings

For External Use Only

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 doctor.
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth before applying.
  • Children under 12: Consult a doctor before using for anal itching.
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 recommended daily dosage unless directed by a doctor
  • In the rectum by using fingers or any mechanical device or applicator
Label 1137 25 (Label 1137-25)

1137-25

Label 1137ub 6 (Label 1137UB-6)

1137UB-6

Other Information
  • Store at room temperature 15º-30ºC (59º-86ºF)
  • Avoid excessive heat
  • Tamper Evident. Do not use if seal is damaged.
Active Ingredients

Hydrocortisone USP 1%

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Petrolateum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days)
  • Bleeding occurs due to anal itching
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

Ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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