SKIN RESTORATIVE- zinc acetate lotion 
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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K5 Restorative

Active Ingredient: Zinc Acetate 0.25%

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

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

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

Purpose Assists in wound healing

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: For external use only.

Avoid contact with eyes.

Principal Label

SKIN RESTORATIVE 
zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70334-155
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.0025 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
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)  
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
CAFFEINE (UNII: 3G6A5W338E)  
SELENIUM (UNII: H6241UJ22B)  
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
MAGNESIUM MG-28 (UNII: OEA937LP27)  
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70334-155-70250 mg in 1 BOTTLE; Type 0: Not a Combination Product02/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/22/2019
Labeler - K5 Brands, LLC (080076713)
Registrant - Kutol Products, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products, Inc.004236139manufacture(70334-155)

Revised: 1/2022
 
K5 Brands, LLC