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, soap as well as for external genital, geminine 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.  Consult a doctor

if you have vaginal discharge.  Consult a doctor

When using this product:

Avoid contact with the eyes

Do not use more than directed unless told to do so by a doctor.

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

If rectal bleeding occurs, consult a doctor promptly

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 and do not begin use of any other hydrocortisone product unless you have asked a doctor.

Directions

for itching of skin irritation, inflammation and rashes:

• 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 and genital itching, adults and children 12 years of age and older:

• 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 applying.
• apply to affected area not more than 3 to 4 times daily.
• children under 12 years of age with external anal itching: consult 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: 51824-097
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: 51824-097-01	28 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2024

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)