topco associates llc. hydrocortisone 1% cream drug facts

topco associates llc. hydrocortisone 1% cream drug facts
SPL v4
SPL
SPL Set ID 11a30ec9-ebc2-4a00-8a8d-431d0d973b37
Route
topical
Published
Effective Date 2022-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
aloe vera leaf oat benzyl alcohol butylated hydroxytoluene cetostearyl alcohol cetyl alcohol chamomile diazolidinyl urea dimethicone distearyldimonium chloride edetate disodium glycerin glyceryl monostearate hydrolyzed jojoba esters (acid form) magnesium ascorbyl phosphate menthyl lactate, (-)- methyl gluceth-20 methylparaben petrolatum polysorbate 60 potassium hydroxide propylparaben water vitamin a palmitate steareth-2 steareth-21 stearyl alcohol stearamidopropyl propylene glycol-dimonium chloride phosphate ppg-12/smdi copolymer .alpha.-tocopherol acetate hydrolyzed bovine elastin (base; 1000 mw)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2020-03-15

Purpose

Anti-itch

Description

Hydrocortisone 1%


Medication Information

Warnings

For external use only

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Purpose

Anti-itch

Directions
  • for itching of skin irritation, inflammation, and rashes:
  • 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, ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily

children under 12 years of age: ask a doctor

Other Information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

Description

Hydrocortisone 1%

Do Not Use
  • for the treatment of diaper rash. Ask a doctor.
  • in the genital area if you have a vaginal discharge. Ask a doctor.
Active Ingredient

Hydrocortisone 1%

Questions Or Comments?

1-888-423-0139

When Using This Product
  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly 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.

Package/label Principal Display Panel

COMPARE TO CORTIZONE •10® INTENSIVE HEALING FORMULA ACTIVE INGREDIENT

Itch & Rash Relief Cream

Intensive Healing Formula

Relieves Itch

Contains Healing Moisturizers Enriched with Vitamins A, C & E

With Antioxidants & Chamomile

TopCare® health

MAXIMUM STRENGTH

Hydrocortisone 1% Cream

ANTI-ITCH CREAM

Intensive Healing Formula

NET WT 1 OZ (28 g)


Structured Label Content

Warnings

For external use only

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Purpose

Anti-itch

Directions
  • for itching of skin irritation, inflammation, and rashes:
  • 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, ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily

children under 12 years of age: ask a doctor

Other Information (Other information)

store at 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

Do Not Use (Do not use)
  • for the treatment of diaper rash. Ask a doctor.
  • in the genital area if you have a vaginal discharge. Ask a doctor.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly 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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

COMPARE TO CORTIZONE •10® INTENSIVE HEALING FORMULA ACTIVE INGREDIENT

Itch & Rash Relief Cream

Intensive Healing Formula

Relieves Itch

Contains Healing Moisturizers Enriched with Vitamins A, C & E

With Antioxidants & Chamomile

TopCare® health

MAXIMUM STRENGTH

Hydrocortisone 1% Cream

ANTI-ITCH CREAM

Intensive Healing Formula

NET WT 1 OZ (28 g)


Advanced Ingredient Data


Raw Label Data

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