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Lucky Supersoft Premium

Dosage form: powder
Ingredients: MENTHOL 0.15g in 100g, ZINC OXIDE 1g in 100g
Labeler: Delta Brands Inc
NDC Code: 20276-979

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 Ingredients
Menthol 0.15%
Zinc Oxide 1.0%

Purpose
Anti-Itch
Skin-Protectant

Uses Temporarily relieves the pain and itch associated with:
  • Minor Cuts
  • Sunburn
  • Insect Bites
  • Scrapes
  • Prickly Heat
  • Minor Burns
  • Rashes
  • Minor Skin Irritations
  • Dries the oozing of poison ivy, oak and sumac


  • Keep out of reach of children.

Warnings
For external use only. When using this product ·Do not get into eyes. Stop use and ask a doctor if ·Condition worsens ·Symptoms last more than 7 days or clear up and occur again within a few days.


Do not use
Do not use on Deep or puncture wounds Animal bites Serious burns. For Powder products Do not use on Broken skin. When using this product Keep away from face and mouth to avoid breathing it.

Directions
Apply as needed, dry skin completely prior to using. Children under 2 years of age, consult a doctor.

Inactive Ingredients Talc, Eucalyptus Oil, Methyl Salicylate, Salicylic Acid, Thymol, Camphor, Zinc Stearate

Package Label


LUCKY SUPERSOFT   PREMIUM
menthol zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-979
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.15 g  in 100 g
ZINC OXIDE (ZINC CATION) ZINC OXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
EUCALYPTUS OIL 
METHYL SALICYLATE 
SALICYLIC ACID 
THYMOL 
CAMPHOR (NATURAL) 
ZINC STEARATE 
Packaging
#Item CodePackage Description
1NDC:20276-979-10283 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/25/2010
Labeler - Delta Brands Inc (102672008)
Establishment
NameAddressID/FEIOperations
Jell Pharmaceuticals Pvt Ltd726025211manufacture

Revised: 11/2010
Document Id: 7229d245-744b-4cbc-b2eb-d8f4653b30bf
Set id: a8643477-33f8-4699-92e3-d9b4e9074308
Version: 2
Effective Time: 20101116
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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