Hydrocortisone by First Aid Only, Inc / Safetec of America, Inc. HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by First Aid Only, Inc, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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

For external use only

Do not use

• in eyes
• for treatment of diaper rash

Stop use, ask a doctor

• if condition worsens 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 dally
• children under 2: ask a doctor

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Packet Label

Anti-Itch
Cream

0.9g (1/32 OZ)

FIRST AID ONLY.

www.FirstAidOnly.com

Fairfield, CT 06824

1.800.835.2263

© 2015 Acme United Corporation.

810002-revA

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62985-5125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10 mg  in 1 g

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: 62985-5125-1	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/10/2015

Labeler - First Aid Only, Inc (196551634)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(62985-5125)