SKIN RESTORATIVE- zinc acetate lotion

Skin Restorative by

Drug Labeling and Warnings

Skin Restorative by is a Otc medication manufactured, distributed, or labeled by K5 Brands, LLC, Kutol Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Zinc Acetate 0.25%

INACTIVE INGREDIENT

Inactive Ingredients Water, Cetearyl Alcohol and Ceteareth-20, DI-C12-15 Alkyl Fumarate, Petrolatum, Mineral Oil, Shea Butter, Dimethicone, Cetylhydroxyproline Palmitamide, Thiotic Acid, Carbomer, Niacinamide, Tocopheryl Acetate, Soy Extract, Hyalauronic Acid, Hydrolyzed Sodium Hyaluronate, Dextrose, Deanol Bitartrate, Pyroxidine Hydrochloride, Vitamin A Acetate, Vitamin D, Caffeine, Ascorbyl Glucoside, Polypodium Leucotomos, Vitamin K1, Vitamin K2, Biochelate Zinc, Biochelate Selenium, Biochelate Magnesium, Biochelate SPF, Collagen Amino Acids, Calcium Carbonate, Glycerin, Fragrance, Lepidium Meyenii Root Extract, L-Citrulline, Triisopropanolamine, Phenostat

DOSAGE & ADMINISTRATION

Directions: Apply liberally twice daily. Gently rub into the skin.

INDICATIONS & USAGE

Uses: Helps heal problen skin areas, including bruises, red areas, and irritation. Continued usage maintains and protects the skin after healing.

PURPOSE

Purpose Assists in wound healing

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of ingestion, contact a physician or poison control center immediately.

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

WARNINGS

Warnings: For external use only.

Avoid contact with eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN RESTORATIVE 
zinc acetate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70334-155
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
DEANOL BITARTRATE (UNII: D240J05W14)
CALCIUM CARBONATE (UNII: H0G9379FGK)
POLYPODIUM LEPIDOPTERIS ROOT (UNII: IA6N785E3M)
PHYTONADIONE (UNII: A034SE7857)
PETROLATUM (UNII: 4T6H12BN9U)
SHEA BUTTER (UNII: K49155WL9Y)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
MENAQUINONE (UNII: 12V8PA4WCH)
ZINC (UNII: J41CSQ7QDS)
LEPIDIUM MEYENII ROOT (UNII: HP7119212T)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
NIACINAMIDE (UNII: 25X51I8RD4)
HYALURONIC ACID (UNII: S270N0TRQY)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
WATER (UNII: 059QF0KO0R)
CETEARETH-22 (UNII: 28VZG1E234)
MINERAL OIL (UNII: T5L8T28FGP)
VITAMIN D (UNII: 9VU1KI44GP)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
GLYCERIN (UNII: PDC6A3C0OX)
NITROSO-DL-CITRULLINE (UNII: S272723IXU)
DIMETHICONE (UNII: 92RU3N3Y1O)
THIOCTIC ACID (UNII: 73Y7P0K73Y)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
CARBOMER 934 (UNII: Z135WT9208)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PEG-20 SOY STEROL (UNII: V5X954S90G)
AMINO ACIDS (UNII: 0O72R8RF8A)
VITAMIN A ACETATE (UNII: 3LE3D9D6OY)
CAFFEINE (UNII: 3G6A5W338E)
SELENIUM (UNII: H6241UJ22B)
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)
MAGNESIUM MG-28 (UNII: OEA937LP27)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70334-155-70	250 mg in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/22/2019

Labeler - K5 Brands, LLC (080076713)

Registrant - Kutol Products, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products, Inc.		004236139	manufacture(70334-155)