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Lucky SuperSoft MAXIMUM STRENGTH

Medically reviewed on February 6, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Delta Brands, Inc
NDC Code: 20276-102

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.

Drug Facts

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

LUCKY SUPERSOFT  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM SULFATE 
YELLOW WAX 
CALCIUM ACETATE 
CETOSTEARYL ALCOHOL 
ICODEXTRIN 
GLYCERIN 
MALTODEXTRIN 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
PROPYLPARABEN 
SODIUM CETOSTEARYL SULFATE 
SODIUM LAURYL SULFATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:20276-102-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2015
Labeler - Delta Brands, Inc (102672008)

 
Delta Brands, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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