supervalu inc. anti-itch ointment drug facts

supervalu inc. anti-itch ointment drug facts
SPL v6
SPL
SPL Set ID ef9ea069-9b97-4bf5-aaac-deb85334dbd0
Route
topical
Published
Effective Date 2021-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
aloe vera leaf petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2010-12-03

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, white petrolatum

Description

Hydrocortisone 1%

Principal Display Panel

EQUALINE®

Compare to Cortizone•10® active ingredient

relieves itch fast

• skin irritation • rashes

• inflammation & redness

• insect bites

• eczema & psoriasis

• water resistant formula

#1 doctor recommended itch relief active ingredient

EQUALINE®

Compare to Cortizone•10® active ingredient

maximum strength

anti-itch ointment

1% hydrocortisone anti-itch ointment

water resistant formula

NET WT 1 OZ (28g)

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

Hydrocortisone 1%

Questions Or Comments?

1-855-423-2630

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
  • •
    rectal bleeding occurs
  • •
    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
Keep Out of Reach of Children.

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


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, white petrolatum

Principal Display Panel

EQUALINE®

Compare to Cortizone•10® active ingredient

relieves itch fast

• skin irritation • rashes

• inflammation & redness

• insect bites

• eczema & psoriasis

• water resistant formula

#1 doctor recommended itch relief active ingredient

EQUALINE®

Compare to Cortizone•10® active ingredient

maximum strength

anti-itch ointment

1% hydrocortisone anti-itch ointment

water resistant formula

NET WT 1 OZ (28g)

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

Hydrocortisone 1%

Questions Or Comments? (Questions or comments?)

1-855-423-2630

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
  • •
    rectal bleeding occurs
  • •
    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
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.


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