LUCKY SUPERSOFT MEDICATED BODY TRIPLE ACTION- menthol zinc oxide powder 
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 Crnstrch menthol zinc oxide Powder

Active Ingredient

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 ■ minor burns ■ minor skin irritations

Warnings

For external use only

Do not use on

■ broken skin ■ deep or puncture wounds ■ serious burns

When using this product

■ avoid contct with eyes ■ ​keep away from face and mouth to avoid breathing powder

Stop use and ask a doctor if

■ if condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

■ for aduts and children 2 years and older: apply freely up to 3 or 4 times daily ■ for children under 2 years: ask a doctor ■ for best results dry skin thoroughly before applying​

Other information

■ this product is sold by weight, not by volume ■ settling will occur during handling & shipping

Inactive ingredients

acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalcium phsphate, zea mays (corn) starch, zinc stearate

Package Label

PAckage Label

LUCKY SUPERSOFT MEDICATED BODY  TRIPLE ACTION
menthol zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-980
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
THYMOL (UNII: 3J50XA376E)  
ZINC STEARATE (UNII: H92E6QA4FV)  
GUM TALHA (UNII: H18F76G097)  
EUCALYPTOL (UNII: RV6J6604TK)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-980-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2017
2NDC:20276-980-14397 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/11/2017
Labeler - Delta Brands Inc (102672008)

Revised: 5/2022
Document Id: dfff9f17-9b4a-dd76-e053-2995a90a7b40
Set id: 603c6f66-93e1-0484-e053-2a91aa0a075a
Version: 2
Effective Time: 20220527
 
Delta Brands Inc