OTC Medication Information: Xpect Hydrocortisone

XPECT HYDROCORTISONE- hydrocortisone cream
Cintas Corporation

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.

Active ingredients (in each gram)

Hydrocortisone 1%

Purpose

Anti-itch cream

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

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.

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 Information

  • clean the affected area
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

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?

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

10_CT_BOX
(click image for full-size original)

10_CT_BOX
(click image for full-size original)

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

20_CT_BOX
(click image for full-size original)

20_CT_BOX
(click image for full-size original)
XPECT HYDROCORTISONE
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-237
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 0.01 g in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
MINERAL OIL
PARAFFIN
PETROLATUM
PROPYLPARABEN
WATER
ALCOHOL
CETOSTEARYL ALCOHOL
POLYSORBATE 60
PEG-150 DISTEARATE
STEARETH-20
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42961-237-02 10 PACKET in 1 BOX contains a PACKET (42961-237-01)
1 NDC:42961-237-01 0.9 g in 1 PACKET This package is contained within the BOX (42961-237-02)
2 NDC:42961-237-03 20 PACKET in 1 BOX contains a PACKET (42961-237-01)
2 NDC:42961-237-01 0.9 g in 1 PACKET This package is contained within the BOX (42961-237-03)
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 Operations
SAFETEC OF AMERICA, INC 874965262 manufacture (42961-237)

Revised: 09/2023 Cintas Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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