CAREALL Hydrocortisone by New World Imports, Inc Drug Facts

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]

CAREALL HYDROCORTISONE  MAXIMUM STRENGTH- hydrocortisone acetate cream 
New World Imports, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Hydrocortisone Acetate 1%

Anti-Itch

If swallowed, get medical help or contact a Poison Control Center immediately.

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

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 toilet tissue or a soft cloth before application of this product.  Children: under 12 years of age with external anal itching: ask a doctor

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

CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone Acetate	10 mg  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)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Chlorocresol (UNII: 36W53O7109)
Edetate Disodium (UNII: 7FLD91C86K)
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: 51824-002-01	28 g in 1 TUBE; Type 0: Not a Combination Product	08/30/2010	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/30/2010	12/31/2019

Labeler - New World Imports, Inc (075372276)

Revised: 10/2019

Document Id: f752c9fe-f8b4-4e44-8234-a0036c3e836b

34390-5

Set id: e3851f61-f6f6-4703-8e70-73954297021c

Version: 6

Effective Time: 20191002

 

New World Imports, Inc