1% Hydrocortisone Cream

1% Hydrocortisone Cream
SPL v7
SPL
SPL Set ID 3d34ae31-265a-46bc-a52d-546ea5bb24b6
Route
TOPICAL
Published
Effective Date 2020-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Edetate Disodium Light Mineral Oil Stearic Acid Glyceryl Monostearate Polyethylene Glycol, Unspecified Cetyl Alcohol Trolamine Methylparaben Propylene Glycol Diazolidinyl Urea Propylparaben Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-04-30

Description

Hydrocortisone acetate (equivalent to  Hydrocortisone 1%)

Purpose

Anti-itch cream


Medication Information

Purpose

Anti-itch cream

Description

Hydrocortisone acetate (equivalent to  Hydrocortisone 1%)

Uses
  • for the temporary relief of itching associated with minor skin irritations and rashes
  • 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 2 years of age and older: apply to affected area not  more than 3 to 4 times daily
  • children under 2 years; do not use, consult a doctor

Do Not Use

for the treatment of diaper rash. Consult a doctor

Questions ?

855-428-6074

www.safeguardmedical.com



Active Ingredient

Hydrocortisone acetate (equivalent to  Hydrocortisone 1%)

Other Information
  • clean the affected area
  • store at room temperature
  • do not use any opened or torn packets
  • you may report a serious adverse reaction to this product to 855-428-6074
Inactive Ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

Principal Display Panel

When Using This Product
  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you've consulted a doctor

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist more than 7 days
  • condition clears up and occurs again within a few days

Keep Out of the 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 and rashes
  • other uses of this product should be only under the advice and supervision of a doctor

Purpose

Anti-itch cream

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; do not use, consult a doctor

Do Not Use (Do not use)

for the treatment of diaper rash. Consult a doctor

Questions ?

855-428-6074

www.safeguardmedical.com



Active Ingredient (Active ingredient)

Hydrocortisone acetate (equivalent to  Hydrocortisone 1%)

Other Information (Other information)
  • clean the affected area
  • store at room temperature
  • do not use any opened or torn packets
  • you may report a serious adverse reaction to this product to 855-428-6074
Inactive Ingredients (Inactive ingredients)

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

Principal Display Panel

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you've consulted a doctor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist more than 7 days
  • condition clears up and occurs again within a few days

Keep Out of the Reach of Children (Keep out of the 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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