Active Ingredient
Hydrocortisone 1%
Hydrocortisone Spray
FDA Label NDC 81522-914
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fsa Store Inc. for the product Hydrocortisone (NDC 81522-914). 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 active ingredient, purpose, uses, warnings, flammable:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
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
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only.
Flammable:
Keep away from fire or flame.
Do Not Use
- for the treatment of diaper rash. Consult a doctor.
When Using This Product
- avoid contact with the eyes
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 consulted a doctor
Keep Out Of The Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older: spray to affected area not more than 3 to 4 times daily
- children under 2 years of age: do not use, consult a doctor.
Other Information
- store at 20 o to 25 oC (68 o to 77 oF)
- shake well before use
- pump must be primed before use
Inactive Ingredients
SD ALCOHOL 40-B, WATER, GLYCERIN, PEG-8, ETHOXYDIGLYCOL, MENTHYL LACTATE, METHYL GLUCETH-20, AVENA SATIVA (OAT) KERNEL EXTRACT, PROPANEDIOL, SODIUM CITRATE, CITRIC ACID.
Questions ?
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Principal Display Panel
caring mill
Maxium Strength
Hydrocortisone 1%
Anti-Itch Spray
Hydrocortisone 1% / Anti-Itch
Ozone-Friendly, Non-Aerosol
Relieves itching from skin irritation,
rashes, insect bites & posion ivy,
oak & sumac
Calms irritated skin
No touch, no mess
SHAKE WELL
2.5 FL. OZ. (74 mL)
Carton (4f546772d2e045ba89af528aee72d062)
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