LUCKY SUPERSOFT MAXIMUM STRENGTH- hydrocortisone cream

Lucky SuperSoft by

Drug Labeling and Warnings

Lucky SuperSoft by is a Otc medication manufactured, distributed, or labeled by Delta Brands, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

■ temporarily relieves itching associated with minor skin irritations and rashes due to: ■ eczema  ■ psoriasis ■ poison ivy, oak, sumac          ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis  ■ temporarily relieves external anal and genital itching    ■ other uses of this product should be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

■ in the genital area if you have vaginal discharge. Consult a doctor ■ for the treatment of diaper rash. Consult a doctor

When using this product

■ avoid contact with 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 or applicator

Stop use and ask a doctor if

■ the condition worsens, symptoms persist for more than 7 days or clear up and occur again wihin a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor ■ rectal bleed 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 water and rinse thoroughly        ■ gently dry by patting or blotting with toilet 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: 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

Package Label

INGREDIENTS AND APPEARANCE

LUCKY SUPERSOFT  MAXIMUM STRENGTH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-102
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-102-14	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/31/2015

Labeler - Delta Brands, Inc (102672008)