LUCKY SUPERSOFT MAXIMUM STRENGTH- hydrocortisone cream 
Delta Brands, 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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Lucky HC Cream 1

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

image description

LUCKY SUPERSOFT  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-102-1414 g in 1 TUBE; Type 0: Not a Combination Product01/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2015
Labeler - Delta Brands, Inc (102672008)

Revised: 9/2023
 
Delta Brands, Inc