Clean Skin Sanitizer: Package Insert and Label Information

CLEAN SKIN SANITIZER- alcohol solution
State Industrial Products

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.

Directions To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

Uses For hand cleaning to decrease bacteria on skin.

Warnings For exernal use only. FLAMMABLE. Keep away from heat or flame. Do not use in the eyes. In case of contact rinse thoroughly. Stp use and ask a doctor if irritation and redness appears and lasts.

Keep Out Of Reach Of Children. If swallowed, contact a physician or poison control center.

Active Ingredient Ethyl Alcohol 62% v/v

Purpose Antibacterial Agent

Inactive Ingredients Water, Acrylates/C10-30 Alkyl Acrylate Crossploymer, Propylene Glycol, Glycerine, Aloe Vera Gel, Fragrance, Triisopropanolamine, Blue 1, Yellow 5.

State Principal label
(click image for full-size original)

CLEAN SKIN SANITIZER
hand sanitizer solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64542-300
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER 934
PROPYLENE GLYCOL 1,2-DISTEARATE
ALOE VERA LEAF
TRIISOPROPANOLAMINE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64542-300-46 675 mL in 1 BOTTLE None
2 NDC:64542-300-35 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/14/2014
Labeler — State Industrial Products (004520987)
Registrant — Kutol Product Company (004236139)
Establishment
Name Address ID/FEI Operations
Kutol Products Company 004236139 manufacture (64542-300)

Revised: 03/2020 State Industrial Products

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