FDA Label for Assured
View Indications, Usage & Precautions
Assured Product Label
The following document was submitted to the FDA by the labeler of this product Zhejiang Jingwei Pharmaceutic Al Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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