SPL v5
SPL
SPL Set ID f0d1b1f7-5a62-4491-b508-91af16649dc3
Route
TOPICAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.01 g)
Inactive Ingredients
Cetyl Alcohol Citric Acid Monohydrate Diazolidinyl Urea Edetate Disodium Anhydrous Glycerin Glyceryl Monostearate Methylparaben Mineral Oil Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-28
Description

Hydrocortisone acetate 1%

Purpose

anti-itch cream

Medication Information

Purpose

anti-itch cream

Description

Hydrocortisone acetate 1%

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

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

Do Not Use
  • with any other hydrocortisone product unless you have consulted a doctor
  • for the treatment of diaper rash, consult a doctor
Questions?

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

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

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.

Principal Display Panel Packet

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

Active Ingredients (in Each Packet)

Hydrocortisone acetate 1%

Principal Display Panel 8 Count Box

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

Principal Display Panel 20 Count Box

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

Principal Display Panel 144 Count Box

144 Pkts per Box

Product #100429

NET WT PER PKT

1/32 OZ (0.9g)

HYDROCORTISONE

1% HYDROCORTISONE ANTI-ITCH CREAM

Xpect® First aid

Structured Label Content

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
Purpose

anti-itch cream

Warnings

For external use only

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

Do Not Use (Do not use)
  • with any other hydrocortisone product unless you have consulted a doctor
  • for the treatment of diaper rash, consult a doctor
Questions?

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

Other Information (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

When Using This Product (When using this product)
  • avoid contact with eyes
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Principal Display Panel Packet (Principal Display Panel - Packet)

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

Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Hydrocortisone acetate 1%

Principal Display Panel 8 Count Box (Principal Display Panel - 8 Count Box)

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

Principal Display Panel 20 Count Box (Principal Display Panel - 20 Count Box)

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

Principal Display Panel 144 Count Box (Principal Display Panel - 144 Count Box)

144 Pkts per Box

Product #100429

NET WT PER PKT

1/32 OZ (0.9g)

HYDROCORTISONE

1% HYDROCORTISONE ANTI-ITCH CREAM

Xpect® First aid

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:06.671416 · Updated: 2026-03-14T23:10:19.800513