Best Choice Anti-itch Cream

Best Choice Anti-itch Cream
SPL v4
SPL
SPL Set ID 2fa104aa-f781-4be8-ba8e-94b53f2b8d81
Route
TOPICAL
Published
Effective Date 2012-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Butylated Hydroxytoluene Carbomer 940 Cetyl Alcohol Glycerin Ethylparaben Glyceryl 1-stearate Propylene Glycol Stearic Acid Trolamine Sodium Lauryl Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-01-30

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

temporarily relieves itching associated with minor skin irritation, 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

Warnings

For external use only

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: 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

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

Package Label

Best Choice Hydrocortisone with Aloe

Active Ingredient

Hydrocortisone 1%

Other Information

store at room temperature

Inactive Ingredient

aloe barbadensis, butylated hydroxytoluene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glycerin monosterate, propylene glycol, purified water, stearic acid sodium lauryl sulfate, trethanolamine

When Using This Product
  • avoid contact with 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.


Structured Label Content

Uses

temporarily relieves itching associated with minor skin irritation, 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

Warnings

For external use only

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: 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

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

Package Label (Package label)

Best Choice Hydrocortisone with Aloe

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)

store at room temperature

Inactive Ingredient (Inactive ingredient)

aloe barbadensis, butylated hydroxytoluene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glycerin monosterate, propylene glycol, purified water, stearic acid sodium lauryl sulfate, trethanolamine

When Using This Product (When using this product)
  • avoid contact with 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.


Advanced Ingredient Data


Raw Label Data

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