Xpect Hydrocortisone
FDA Label NDC 42961-220

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corp for the product Xpect Hydrocortisone (NDC 42961-220). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each packet), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (In Each Packet)

Hydrocortisone acetate 1%

Purpose

anti-itch cream

Uses

temporarily relieves itching associated with minor skin irritations and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak, or sumac
  • soaps, detergents, or cosmetics
  • jewelry

Warnings

For external use only

Do Not Use

  • with any other hydrocortisone product unless you have consulted a doctor
  • for the treatment of diaper rash, consult a doctor

When Using This Product

  • avoid contact with eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 adults and children

 2 years and over

 apply to affected area not more

 than 3 to 4 times daily

 children under 2 years do not use, consult a physician

Other Information

  • do not use if package is torn, cut or opened
  • store at room temperature (do not freeze)
  • see packet for Lot Number and expiration date

Inactive Ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monosterate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions?

1-877-973-2811 Monday-Friday 8:00am-5:00pm

Packet Label - 42961-212-01

Front-label.jpg (Front Label)

Front-label.jpg (Front Label)

HYDROCORTISONE

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

NET WT. 1/32 oz. (0.9g)

Anti-Itch Cream

USES: For the temporary relief of itching and rashes associated with minor skin irritations due to eczema, insect bites, poison ivy/oak/sumac, soaps, cosmetics & other similar skin irritations.

DO NOT USE IF PACKET IS TORN OR OPEN.

Xpect® First aid

Back-label.jpg (Back Label)

Back-label.jpg (Back Label)

SEE BOX OR DRUG FACTS CARD FOR COMPLETE WARNINGS

Mfg. by Cintas First Aid & Safety 

Mason, OH 45040

PACKET NOT FOR INDIVIDUAL SALE 

(5/15) #100409

8 Pack Label - 42961-212-03

8-pck-label.jpg (8 Pck Label)

8-pck-label.jpg (8 Pck Label)

HYDROCORTISONE

Xpect® First aid

HYDROCORTISONE

1% HYDROCORTISONE ANTI-ITCH CREAM

Xpect® First Aid

Distributed by Cintas First Aid & Safety

Mason, OH 45040

Product #181269

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and other skin irritations.

NET WT PER PKT 1/32 OZ (0.9g)

8 Packets per Box

20 Pack Label - 42961-212-02

20-pck-label.jpg (20 Pck Label)

20-pck-label.jpg (20 Pck Label)

HYDRO-CORTISONE

Xpect® First aid

20 Pkts per Box

Product #100419

HYDRO-CORTISONE

1% HYDROCORTISONE ANTI-ITCH CREAM

Xpect® First aid

HYDRO-CORTISONE 

1% HYDROCORTISONE ANTI-ITCH CREAM

Xpect® First aid

Distributed by: Cintas

Mason, OH 45040

www.cintas.com

For the temporary relief of itching associated with minor skin irritations, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and other skin irritations.

NET WT PER PKT

1/32 OZ (0.9g)

20 Pkts per Box

144 Pack Label - 42961-212-04

144-pck-label.jpg (144 Pck Label)

144-pck-label.jpg (144 Pck Label)

144 Pkts per Box

Product #100429

NET WT PER PKT

1/32 OZ (0.9g)

HYDROCORTISONE

1% HYDROCORTISONE ANTI-ITCH CREAM

Xpect® First aid

* Please review the disclaimer below.