ITCH RELIEF CREAM- hydrocortisone cream cream

Itch relief Cream by

Drug Labeling and Warnings

Itch relief Cream by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, ULTRAtab Laboratories, Inc. , Ultra Seal Corporation . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: HYDROCORTISONE 1%Cream.

PURPOSE

Itch Relief Cream

INACTIVE INGREDIENT

Inactive Ingredients: Benzoic Acid, Chlorphenesin, Citric Acid, Glycerin,Glycerol Monostearate, Methyl Paraben, Mineral Oil,Petrolatum, Phenoxyethanol,Polysorbate 80,Purified Water, Titanium Dioxide,Trisodium Citrate

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

USES: For the temporary relief of itching associated with minor, skin irritations and rashes due to eczema, insect bites, poison ivy/oak/sumac, soaps, detergents,cosmetics and jewelry

DOSAGE & ADMINISTRATION

DIRECTIONS: Adults and children 2years of age and older: apply to affected area and not more than 3 to4 times daity. Children under 2: do not use, consult a doctor.

WARNINGS

WARNINGS: For external use only. Avoid contact with eyes. Discontinue use If conditions persist more than 7 days and consult a physician. Do not use on children under 2 years except under the advice and supervision of a physician. Do not use with any other hydrocortisone product unless you have consulted a doctor. Other uses or this product should be only under the advise or supervision of a doctor.

OTHER SAFETY INFORMATION

Store at room temperature (do not freeze).

PACKET NOT FOR INDIVIDUAL SALE

Tamper evident: Do not use if package is torn or cut.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ITCH RELIEF CREAM 
hydrocortisone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-370
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
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MINERAL OIL (UNII: T5L8T28FGP)
BENZOIC ACID (UNII: 8SKN0B0MIM)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-370-09	0.9 g in 1 PACKET; Type 0: Not a Combination Product	11/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/29/2016

Labeler - Cintas (056481716)

Registrant - ULTRAtab Laboratories, Inc. (151051757)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(42961-370)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(42961-370)