LUCKY SUPERSOFT MEDICATED BODY TRIPLE ACTION- menthol zinc oxide powder

Lucky Supersoft Medicated Body by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

Directions

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

INGREDIENTS AND APPEARANCE

LUCKY SUPERSOFT MEDICATED BODY  TRIPLE ACTION
menthol zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-980
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GUM TALHA (UNII: H18F76G097)
EUCALYPTOL (UNII: RV6J6604TK)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-980-08	227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/11/2017

Labeler - Delta Brands Inc (102672008)