DIABETIC SKIN CARE FORMULA- zinc acetate soap
K5 BRANDS, LLC

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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PURPOSE

Assist in wound healing

ACTIVE INGREDIENT

Zinc Acetate .............25%

INACTIVE INGREDIENTS

CETEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
DI-C12-15 ALKYL FUMARATE
PETROLATUM
MINERAL OIL
SHEA BUTTER
DIMETHICONE
CETYLHYDROXYPROLINE PALMITAMIDE
ALPHA LIPOIC ACID
WATER
CARBOMER HOMOPOLYMER
NIACINAMIDE
TOCOPHERYL ACETATE
SOYBEAN

HYALURONIC ACID
HYALURONATE SODIUM
DEXTROSE
PANTHENOL
PYRIDOXINE HYDROCHLORIDE
VITAMIN A ACETATE
VITAMIN D

INDICATIONS AND USAGE

Treats and prevents skin breakdown due to circulation and nutrition problems

Apply to affected area at least twice daily for treatment and prevention

WARNINGS

For external use only.

Avoid contact with eyes.

In case of indegestion contact a poison control center or physician immediately

If condition worsens or does not improve within 7 days, consult physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PACKAGE LABEL

LABEL

DIABETIC SKIN CARE FORMULA
zinc acetate soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70334-152
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.0025 mg in 1 mg

Ingredient Name	Strength
Inactive Ingredients
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SOYBEAN (UNII: L7HT8F1ZOD)
HYALURONIC ACID (UNII: S270N0TRQY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DEXTROSE (UNII: IY9XDZ35W2)
PANTHENOL (UNII: WV9CM0O67Z)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
VITAMIN A ACETATE (UNII: 3LE3D9D6OY)
VITAMIN D (UNII: 9VU1KI44GP)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70334-152-60	250 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/31/2016

Labeler - K5 BRANDS, LLC (080076713)