ANTI-ITCH- hydrocortisone cream

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

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

Do not use

• in eyes
• for treatment of diaper rash
• for feminine itching

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

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

Principal Display Panel - Welly Health Hydrocortisone Cream Pouch Label

Welly™

1% Hydrocortisone
Cream

0.9g/ 1/32 OZ

INGREDIENTS AND APPEARANCE

ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-580
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
hydrocortisone (UNII: WI4X0X7BPJ) (hydrocortisone - UNII:WI4X0X7BPJ)	hydrocortisone	1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
alcohol (UNII: 3K9958V90M)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
petrolatum (UNII: 4T6H12BN9U)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
white wax (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-580-02	0.9 mL in 1 POUCH; Type 0: Not a Combination Product	02/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/25/2019

Labeler - Welly Health PCB (116766884)