Label: XPECT HYDROCORTISONE- hydrocortisone cream
- NDC Code(s): 42961-237-01, 42961-237-02, 42961-237-03
- Packager: Cintas Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 20, 2023
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- ACTIVE INGREDIENT
- PURPOSE
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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
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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
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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 - QUESTIONS
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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
-
INGREDIENTS AND APPEARANCE
XPECT HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-237 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) STEARETH-20 (UNII: L0Q8IK9E08) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-237-02 10 in 1 BOX 09/12/2023 1 NDC:42961-237-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:42961-237-03 20 in 1 BOX 09/12/2023 2 NDC:42961-237-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/12/2023 Labeler - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations SAFETEC OF AMERICA, INC 874965262 manufacture(42961-237)
