Xpect Hydrocortisone Cream
FDA Label NDC 42961-237

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 Corporation for the product Xpect Hydrocortisone (NDC 42961-237). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Safety Information

→ Inactive Ingredient

→ Otc - Questions

→ Principal Display Panel 42961-235-02

→ Principal Display Panel 42961-235-03

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

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