Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1df6f9ac-d564-4304-a99d-5056670be66f
Route
TOPICAL
Published
Effective Date 2011-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Citric Acid Monohydrate Dodecyl-2-n,n-dimethylaminopropionate Hydrochloride Glycerin Glyceryl Monostearate Methylparaben Petrolatum Polysorbate 80 Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-08-19

Description

Hydrocortisone 1%

Purpose

Anti-itch cream


Medication Information

Purpose

Anti-itch cream

Description

Hydrocortisone 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, scrapes
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 51945-4

Warnings

For external use only.

Directions
  • For 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: do not use, consult a doctor
  • Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • Gently dry by patting or blotting toilet tissue or a soft cloth before application of this product
  • Children under 12 years of age: for external itching consult a doctor
Do Not Use
  • for the treatment of diaper rash. Ask a doctor
  • in the genital area if you have vaginal discharge. Ask a doctor



Questions?

Call 1-800-866-7391, Mon-Fri, 8:30 AM - 5:30 PM (PST)

Active Ingredient

Hydrocortisone 1%

Other Information
Store between 20 and 25C (68 to 77F)
Inactive Ingredients

citric acid, dodecyl-2-N N-dimethylaminopropionate hydrochloride, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

When Using This Product
  • avoid contact with the eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

  • rectal bleeding occurs

Keep Out of Reach of Children

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


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, scrapes
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 51945-4 (51945-4)

Purpose

Anti-itch cream

Warnings

For external use only.

Directions
  • For 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: do not use, consult a doctor
  • Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • Gently dry by patting or blotting toilet tissue or a soft cloth before application of this product
  • Children under 12 years of age: for external itching consult a doctor
Do Not Use (Do not use)
  • for the treatment of diaper rash. Ask a doctor
  • in the genital area if you have vaginal discharge. Ask a doctor



Questions?

Call 1-800-866-7391, Mon-Fri, 8:30 AM - 5:30 PM (PST)

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)
Store between 20 and 25C (68 to 77F)
Inactive Ingredients

citric acid, dodecyl-2-N N-dimethylaminopropionate hydrochloride, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

  • rectal bleeding occurs

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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