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

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

Purpose

Anti-itch

Description

Hydrocortisone 1.0%

Medication Information

Warnings

External use only

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

Directions

apply to affected area not more than 3 to 4 times daily
children under 2: ask a doctor

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

Description

Hydrocortisone 1.0%

Do Not Use

in eyes
for treatment of diaper rash
for feminine itching

Active Ingredient

Hydrocortisone 1.0%

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

Warnings

External use only

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

Directions

apply to affected area not more than 3 to 4 times daily
children under 2: ask a doctor

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

Do Not Use (Do not use)

in eyes
for treatment of diaper rash
for feminine itching

Active Ingredient (Active ingredient)

Hydrocortisone 1.0%

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

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Raw Label Data

All Sections (JSON)

{"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": "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"}

Additional Information

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