Hydrocortisone by ADVANCED FIRST AID, INC. / ULTRA SEAL CORPORATION / ULTRA TAB LABORATORIES, INC. HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT (in each gram)- Hydrocortisone USP 10mg

PURPOSE

Antipruritic (Anti-Itch)

INDICATIONS & USAGE

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

for external genital, feminine and anal itching other uses of this product should be only under the

advice and supervision of a doctor

WARNINGS

Warnings:

for external use only do not use for the treatment of diaper rash

Consult a doctor: before use if you have a vaginal discharge (for external feminine itching)

for external itching, do not exceed the recommended daily dosage or if bleeding occurs

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within

a few days

When using this product: avoid contact with eyes do not put this product into rectum by using

fingers or any mechanical device or applicator

Do Not Use: with any other Hydrocortisone product unless you have consulted a doctor.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control

Center right away.

DOSAGE & ADMINISTRATION

Directions: For adults and children 2 years of age and older: apply to affected area 1 to 2 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.

INACTIVE INGREDIENT

Inactive Ingredients:

citric acid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbate 80, propylene glycol, propyl

paraben, purified water, sodium citrate and titanium dioxide.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-370
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-370-39	25 in 1 CARTON	04/08/2015
1	NDC: 67060-370-09	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	04/08/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-370)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-370)