Hydrocortisone Cream 1%

Hydrocortisone Cream 1%
SPL v2
SPL
SPL Set ID 64adc8d0-7ca4-4c1a-813f-f1df47e916f2
Route
TOPICAL
Published
Effective Date 2024-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.9 g)
Inactive Ingredients
Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-02-02
Description

Drug Facts

Purpose

Anti-Itch Cream

Medication Information

Purpose

Anti-Itch Cream

Description

Drug Facts

Use

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
Section 42229-5

Drug Facts

Warnings

For external use only

Directions
  • Adults and children two years and over: apply to affected area not more than three to four times daily
  • Children under two years: 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?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

Active Ingredient

Hydrocortisone acetate 1%

Other Information
  • Do not use if packet is torn, cut or opened
  • Store at room temperature (do not freeze)
  • See packet for Lot Number and expiration date
Inactive Ingredient

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin/Phenoxyethanol Glycerin, Glycerol fatty acid ester Mineral Oil, Petrolatum, Water

Stop Use and Ask A Doctor If
  • Condition worsens
  • Symptoms persist for more than seven 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 25 Packet Carton

Product #1014

Hydrocortisone Cream

USP 1%

For the temporary relief of itching

associated with minor skin

irritations and rashes.

25 - Unit Dose Packets

Structured Label Content

Use

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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Anti-Itch Cream

Warnings

For external use only

Directions
  • Adults and children two years and over: apply to affected area not more than three to four times daily
  • Children under two years: Do not use
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?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

Active Ingredient (Active ingredient)

Hydrocortisone acetate 1%

Other Information
  • Do not use if packet is torn, cut or opened
  • Store at room temperature (do not freeze)
  • See packet for Lot Number and expiration date
Inactive Ingredient (Inactive ingredient)

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin/Phenoxyethanol Glycerin, Glycerol fatty acid ester Mineral Oil, Petrolatum, Water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • Symptoms persist for more than seven 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 25 Packet Carton (PRINCIPAL DISPLAY PANEL - 25 Packet Carton)

Product #1014

Hydrocortisone Cream

USP 1%

For the temporary relief of itching

associated with minor skin

irritations and rashes.

25 - Unit Dose Packets

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.689758 · Updated: 2026-03-14T23:02:54.359020