FDA Label for Xpect Hydrocortisone
View Indications, Usage & Precautions
Xpect Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Cintas Corporation. 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 (in each gram)
Hydrocortisone 1%
Otc - Purpose
Purpose
Anti-itch cream
Indications & Usage
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, and scrapes
- other uses of product should be only under the advice and supervision of a doctor
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
- for the treatment of diaper rash
- in eyes
- for feminine itching
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or lasts more than 7 days, or clears up and ocurs again within a few days
- you begin use of any other Hydrocortisone product unless you have consulted a doctor
- if bleeding occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
- children under 12 years of age: for external anal itching, consult a doctor
- children under 2: do not use, consult a doctor
- adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Other Safety Information
Other Information
- clean the affected area
- store at room temperature (do not freeze)
- do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
cetyl alcohol*, citric acid*, diazolidinyl urea*, edetate disodium*, emulsifying wax*, ethanol*, glycerin*, glyceryl monostearate*, methylparaben, mineral oil, paraffin*, petrolatum*, polyethylene glycol*, propylene glycol*, propylparaben, stearic acid*, trolamine*, water, white wax*
*may contain ingredient
Otc - Questions
Questions?
1-877-973-2811 M-F 8 am - 5 pm
Principal Display Panel 42961-235-02
HYDROCORTISONE
Active Ingredient:
Hydrocortisone 1%
Anti-itch cream
For temporary relief of itching associated with minor skin irritations, inflammation, or rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and otehr skin irritations.
Distributed by: Cintas • Mason, OH 45040 • www.cintas.com
Xpect® First aid
NET WT PER PKT 1/32 OZ (0.9g)
10 Packets per Box
Principal Display Panel 42961-235-03
HYDROCORTISONE
Hydrocortisone 1%
Anti-itch cream
For temporary relief of itching associated with minor skin irritations, inflammation, or rashes.
Xpect® First aid
Distributed by: Cintas • Mason, OH 45040 • www.cintas.com
NET WT PER PKT 1/32 OZ (0.9g)
20 Packets per Box
* Please review the disclaimer below.