Avedana ®

Avedana ®
SPL v17
SPL
SPL Set ID 2a55c426-39b4-4d94-b6b4-6c548c9685e9
Route
TOPICAL
Published
Effective Date 2021-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10.2 mg)
Inactive Ingredients
Water Glycerin Cetostearyl Alcohol Cetyl Palmitate Isostearyl Neopentanoate Methylparaben Isopropyl Myristate Peg-40 Stearate Polyoxyl 20 Cetostearyl Ether Benzyl Alcohol Aloe Vera Leaf

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-07

Description

Hydrocortisone, USP 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone, USP 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

*jewelry    *detergents    *cosmetics    *psoriasis    *seborrheic dermatitis

*for external gential, feminine and anal itching    *other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Avedana ®

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 of age *do not use, consult a doctor

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a solft cloth before application of this product.

Children under 12 years of age: consult a doctor

Do Not Use

*for external feminine itching if you have a vaginal discharge. Consult a doctor.

*for the treatment of diaper rash. Consult a doctor.

Questions?

724-733-7381

Active Ingredient

Hydrocortisone, USP 1%

Other Information
  • Storage temperature: not to exceed 30 °C (86 °F). Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients

aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water.  May contain citric acid or sodium citrate solution to adjust pH.

When Using This Product

*avoid contact with the eyes    *do not begin the use of any other hydrocortisone product unless directed by a doctor

*for external anal itching

    *do not use more than directed unless directed by a doctor

    *do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If

*symptoms last for more than 7 days    *the condition gets worse    *symptoms clear up and occur again in a few days

*rectal bleeding occurs, consult doctor promptly

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

*jewelry    *detergents    *cosmetics    *psoriasis    *seborrheic dermatitis

*for external gential, feminine and anal itching    *other uses of this product should be only under the advice and supervision of a doctor

Purpose

Anti-itch

Warnings

For external use only

Avedana ®

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 of age *do not use, consult a doctor

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a solft cloth before application of this product.

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

*for external feminine itching if you have a vaginal discharge. Consult a doctor.

*for the treatment of diaper rash. Consult a doctor.

Questions?

724-733-7381

Active Ingredient (Active ingredient)

Hydrocortisone, USP 1%

Other Information (Other information)
  • Storage temperature: not to exceed 30 °C (86 °F). Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients (Inactive ingredients)

aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water.  May contain citric acid or sodium citrate solution to adjust pH.

When Using This Product (When using this product)

*avoid contact with the eyes    *do not begin the use of any other hydrocortisone product unless directed by a doctor

*for external anal itching

    *do not use more than directed unless directed by a doctor

    *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)

*symptoms last for more than 7 days    *the condition gets worse    *symptoms clear up and occur again in a few days

*rectal bleeding occurs, consult doctor promptly

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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