Drug Facts - Active Ingredient
Hydrocortisone 1.0%
Anti Itch Spray
FDA Label NDC 13709-327
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Anti Itch (NDC 13709-327). 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 drug facts - active ingredient, purpose, uses, warnings, warnings : do not use:, warnings : ask a doctor before use if, warnings : stop use and ask doctor, warnings: keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Itch
Uses
Temporarily alleviates itching associated with minor skin irritation, inflammation and rashes due to:
- Eczema
- Poison ivy, oak and sumac
- Psoriasis
- Soaps and detergents
- Cosmetics
- Jewelry
- Insect bites
- Seborheic dermatitis
Warnings
For external use only.
Flammable: Do not use while smoking or near heat or flame
Warnings : Do Not Use:
In or near the eyes; for diaper rash ask a doctor. In case of an accidental exposure rinse with water or saline immediately, remove contact lenses and sesk medical help for any persistent symptoms. Use only as directed. Do not puncture or incinerate. Contents under pressure. Avoid long term storage above 104°F. Do not store at temperatures above 120°F.
Warnings : Ask A Doctor Before Use If
you are using any other hydrocortisone or corticosteroid product.
Warnings : Stop Use And Ask Doctor
if condition worsens or does not improve within 7 days, or clears up and occurs again within a few days.
Warnings: Keep Out Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away. 1-800-222-1222
Directions:
Shake well
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 - to apply to face, spray into palm of hand and gently apply
Inactive Ingredients:
Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, USP grade purified Water.
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