Hydrocortisone by Safetec of America, Inc. HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses:

• for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
• other uses of this product should be only under the advice and supervision of a doctor

Warnings:

• For external use only

• Do not use for the treatment of diaper rash
• in eyes
• for feminine itching
• if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
• with any other Hydrocortisone product unless you have consulted a doctor

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
• children under 2 years of age: do not use, consult a doctor
• adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• children under 12 years of age: for external anal itching, consult a doctor

Other information:

• store at room temperature (do not freeze)
• do not use any opened or torn packets

Inactive ingredients:

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

Questions or Comments? 1-800-456-7077

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 . 800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

Safetec

1% Hydrocortisone Cream™

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

PRINCIPAL DISPLAY PANEL – Box Label

NDC: 61010-5800-2

Safetec

First Aid

1% Hydrocortisone Cream

For Temporary Relief of

Itching Associated with

Minor Skin Irritations,

Inflammation, or Rashes

Reorder no. 53110

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

PRINCIPAL DISPLAY PANEL – 10 Packet Box Label

Safetec®

FIRST AID

Hydrocortisone Cream

1% Hydrocortisone for relief from itching,
inflammation, and rashes

10 Packets

Each Packet Net Wt. 0.9g

Made in USA

Reorder no. 53108

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-5800
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)
cetostearyl alcohol (UNII: 2DMT128M1S)
polysorbate 60 (UNII: CAL22UVI4M)
PEG-150 distearate (UNII: 6F36Q0I0AC)
steareth-20 (UNII: L0Q8IK9E08)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-5800-3	25 in 1 BOX	12/15/2010
1	NDC: 61010-5800-1	0.9 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 61010-5800-2	144 in 1 BOX	12/15/2010
2	NDC: 61010-5800-1	0.9 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 61010-5800-4	10 in 1 BOX	04/01/2020
3	NDC: 61010-5800-1	0.9 g in 1 POUCH; 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	12/15/2010

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-5800)