Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a90e7759-c697-4b3c-bdb6-fd3a343e8e7e
Route
TOPICAL
Published
Effective Date 2019-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Alcohol Methylparaben Mineral Oil Paraffin Petrolatum Propylparaben Water White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-25
Description

Hydrocortisone 1.0%

Purpose

Anti-itch

Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1.0%

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Other uses of product should be only under the advice and supervision of a doctor.

Warnings

External use only

Directions
  • apply to affected area not more than 3 to 4 times daily
  • children under 2: ask a doctor
Do Not Use
  • in eyes
  • for treatment of diaper rash
  • for feminine itching
Active Ingredient

Hydrocortisone 1.0%

Inactive Ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Stop Use, Ask A Doctor
  • if conditions worsen or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products
Keep Out of Reach of Children.

If ingested, contact a Poison Control Center right away

Principal Display Panel Welly Health Hydrocortisone Cream Pouch Label

Welly™

1% Hydrocortisone

Cream

0.9g/ 1/32 OZ

Structured Label Content

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Other uses of product should be only under the advice and supervision of a doctor.

Purpose

Anti-itch

Warnings

External use only

Directions
  • apply to affected area not more than 3 to 4 times daily
  • children under 2: ask a doctor
Do Not Use (Do not use)
  • in eyes
  • for treatment of diaper rash
  • for feminine itching
Active Ingredient (Active ingredient)

Hydrocortisone 1.0%

Inactive Ingredients (Inactive ingredients)

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Stop Use, Ask A Doctor (Stop use, ask a doctor)
  • if conditions worsen or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products
Keep Out of Reach of Children. (Keep out of reach of children.)

If ingested, contact a Poison Control Center right away

Principal Display Panel Welly Health Hydrocortisone Cream Pouch Label (Principal Display Panel - Welly Health Hydrocortisone Cream Pouch Label)

Welly™

1% Hydrocortisone

Cream

0.9g/ 1/32 OZ

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:21.413701 · Updated: 2026-03-14T23:01:50.647319