XPECT HYDROCORTISONE- hydrocortisone cream

Xpect Hydrocortisone by

Drug Labeling and Warnings

Xpect Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, SAFETEC OF AMERICA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each gram)

Hydrocortisone 1%

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.

Do not use

• for the treatment of diaper rash
• in eyes
• for feminine itching

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

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

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

INGREDIENTS AND APPEARANCE

XPECT HYDROCORTISONE 
hydrocortisone cream

Product 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)