FDA Label for Hydrocortisone
View Indications, Usage & Precautions
Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Premier Brands Of America, Inc.. 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.
Active Ingredient
Hydrocortisone 1%
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
- jewelry
- detergents
- cosmetics
- 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 heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 °F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
Do Not Use
- for external genital, vaginal or anal itching
- with other hydrocortisone product unless directed by a doctor
- in or near the eyes
- for diaper rash
When Using This Product
- avoid contact with the eyes
- if product gets into the eye, flush with water for 15 minutes
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
- twist cap counterclockwise to unlock actuator
- adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
- children under 2 years of age: do not use, consult a doctor
- to apply to face, spray into palm of hand and gently apply
Inactive Ingredients
aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, SD alcohol 40-B, sodium citrate, water
Questions ?
Call 1-866-964-0939
Principal Display Panel
Cutter
Poison Ivy Itch Relief
For Poison Ivy, Oak, & Sumac
Maximum Strength
Relieves Itching
Calms irritated skin
No touch, no mess
HYDROCORTISONE 1% / ANTI-ITCH
NET WT 4.0 0Z (113 g)
* Please review the disclaimer below.