Assured Cream
FDA Label NDC 55621-018

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutic Al Co., Ltd. for the product Assured (NDC 55621-018). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

Hydrocortisone 1%

Otc - Purpose

Purpose

Anti-itch

Indications & Usage

Uses

•temporarily relieves itching ssociated with minor skin

irritation, inflammation and rashesdue 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 be under advice and

supervision of a doctor

Warnings

Warnings. For external use only.

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.

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 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical

help or contract a Poison Control Center right away.

Dosage & Administration

Directions

• for relieving 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 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

Storage And Handling

Other information

•store at room temperature 68° - 77° F (20° - 25° C)

Inactive Ingredient

Inactive ingredients aloe barbadensis leaf juice, cetyl alcohol,

dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate,

isohexadecane, maltodextrin, methyl gluceth-20, methyparaben, petrolatum,

phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic

acid, tocopherol, water, zingiber officinale (ginger) root extract

Otc - Questions

Questions? 1-800-639-3803  Weekdays 9 AM to 4 PM EST

Package Label.Principal Display Panel

Image Description (Hydro 018)

Image Description (Hydro 018)

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