Market Basket Anti-Itch Cream Plus by Davion, Inc. Drug Facts

Drug Details [pdf]

MARKET BASKET ANTI-ITCH CREAM PLUS- hydrocortisone cream
Davion, 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

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewelry
cosmetics
soaps
seborrheic dermatitis
temporary relieves external anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

in the genital area if you have a vaginal discharge. Consult a doctor
for the treatment of diaper rash, 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 directly into the rectum by using fingers or any mechanical device

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. Do not begin use of any other hydrocortisone product unless you have consulted a doctor
rectal bleeding occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away

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: ask a doctor
for external anal and genital itching, adults:
when practical, clean the affected area with mild soap and warm water and rinse thoroughly
gently dry by patting or blotting with toilet tissue or soft cloth before applying
apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Other Information

do not use if tube seal under cap is broken, missing, or if the tube tip is cut prior to opening

Inactive Ingredients

aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water

MARKET BASKET ANTI-ITCH CREAM PLUS
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42669-215
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM SULFATE (UNII: 34S289N54E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CALCIUM ACETATE (UNII: Y882YXF34X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ICODEXTRIN (UNII: 2NX48Z0A9G)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 42669-215-28	28 g in 1 TUBE; Type 0: Not a Combination Product	03/06/2016	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/06/2016	08/01/2023

Labeler - Davion, Inc. (174542928)

Registrant - Davion, Inc. (174542928)

Name	Address	ID/FEI	Business Operations
Establishment
Davion Inc		079536689	manufacture(42669-215)

Revised: 8/2023

Document Id: 01e29ed2-c0ba-5e27-e063-6394a90a96d5

Set id: 94dd0d77-b441-4763-b768-00aa81d1622e

Version: 5

Effective Time: 20230801