Xpect Hydrocortisone

Xpect Hydrocortisone
SPL v3
SPL
SPL Set ID 45ef9be4-54c4-4d85-966b-27708313ded4
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
Methylparaben Mineral Oil Paraffin Petrolatum Propylparaben Water Alcohol Cetostearyl Alcohol Polysorbate 60 Peg-150 Distearate Steareth-20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-12

Description

Active ingredients (in each gram) Hydrocortisone 1%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and 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 
Dosage and 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
Description

Active ingredients (in each gram) Hydrocortisone 1%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 

Section 50566-9

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
Section 50570-1

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
Section 51727-6

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

Section 53413-1

Questions?

1-877-973-2811 M-F 8 am - 5 pm

Section 55105-1

Purpose

Anti-itch cream

Section 55106-9

Active ingredients (in each gram)

Hydrocortisone 1%

Section 60561-8

Other Information

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


Structured Label Content

Indications and Usage (34067-9)

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 
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 

Section 50566-9 (50566-9)

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
Section 50570-1 (50570-1)

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions?

1-877-973-2811 M-F 8 am - 5 pm

Section 55105-1 (55105-1)

Purpose

Anti-itch cream

Section 55106-9 (55106-9)

Active ingredients (in each gram)

Hydrocortisone 1%

Section 60561-8 (60561-8)

Other Information

  • clean the affected area
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Principal Display Panel 42961 235 02 (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 other 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 (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


Advanced Ingredient Data


Raw Label Data

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