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 right away

Uses

• For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:   eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soap
• 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.  Consult a doctor

When using this product:

Avoid contact with the eyes

Do not begin use of any other hydrocortisone product unless you have consulted a doctor

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.

INACTIVE INGREDIENT

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Propylene Glycol (UNII: 6DC9Q167V3)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
Mineral Oil (UNII: T5L8T28FGP)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
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: 51824-098-14	144 in 1 BOX	01/01/2024
1	NDC: 51824-098-09	.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 51824-098-25	25 in 1 BOX	01/01/2024
2	NDC: 51824-098-09	.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 Drug	M017	01/01/2024

Labeler - New World Imports, Inc (075372276)