CAREALL HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream

CAREALL Hydrocortisone by

Drug Labeling and Warnings

CAREALL Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Keep out of reach of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal itching.

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.  Ask a doctor

For external genital itching if you have a vaginal discharge.  Ask a doctor

When using this product:

Avoid contact with the eyes

Do not begin use of any other Hydrocortisone product unless you have asked a doctor

For external anal itching do not exceed the recommended daily dosage unless directed by a doctor.  In case of bleeding, consult a doctor promptly.

Do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if:

Condition worsens

Symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years of age and older:

• apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age:

• do not use.  Ask a doctor.

For external anal itching:

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.  Gently dry by patting or blotting with toliet tissue or a soft cloth before application of this product.
• children under 12 years of age with external anal itching: ask a doctor.

INACTIVE INGREDIENT

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone Acetate	1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Propylene Glycol (UNII: 6DC9Q167V3)
Petrolatum (UNII: 4T6H12BN9U)
Mineral Oil (UNII: T5L8T28FGP)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
Chlorocresol (UNII: 36W53O7109)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	white (White Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-050-01	28 g in 1 TUBE; Type 0: Not a Combination Product	04/27/2016
2	NDC: 51824-050-09	.9 g in 1 PACKET; Type 0: Not a Combination Product	04/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/11/2016

Labeler - New World Imports, Inc (075372276)