Clean Hands Antibacterial Hand Sanitizer: Package Insert and Label Information

CLEAN HANDS ANTIBACTERIAL HAND SANITIZER- alcohol gel
ENCHANTE ACCESSORIES INC.

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.

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

■ Hand sanitizer to help decrease bacteria on the skin
■When water, soap & towel are not available.
■Recommended for repeated use,

WARNINGS

For external use only■ Flammable
Keep away from fire or flame
Do not apply around eyes. Do not use in ears & mouth.
When using this product. avoid contact with eyes.
In case of contact flush eyes with water
Stop use and ask a doctor it redness or irritation
develop and persist for more than 72 hours

keep out of reach of children

Keep out of reach of children. Children must be supervised in use of this product

Directions

Pump as needed into your palms and thoroughly
spread on both hands. Rub into skin until dry
Other Information Store at 20C(88″ to 77″F)
May discolor fabrices

Inactive ingredients

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine

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CLEAN HANDS ANTIBACTERIAL HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-195
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
ALOE VERA LEAF
TROLAMINE
CARBOMER 934
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50563-195-01 200 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (50563-195-01)
2 NDC:50563-195-02 150 BOTTLE in 1 CARTON contains a BOTTLE
2 60 mL in 1 BOTTLE This package is contained within the CARTON (50563-195-02)
3 NDC:50563-195-03 100 BOTTLE in 1 CARTON contains a BOTTLE
3 100 mL in 1 BOTTLE This package is contained within the CARTON (50563-195-03)
4 NDC:50563-195-04 24 BOTTLE in 1 CARTON contains a BOTTLE
4 237 mL in 1 BOTTLE This package is contained within the CARTON (50563-195-04)
5 NDC:50563-195-05 20 BOTTLE in 1 CARTON contains a BOTTLE
5 500 mL in 1 BOTTLE This package is contained within the CARTON (50563-195-05)
6 NDC:50563-195-06 18 BOTTLE in 1 CARTON contains a BOTTLE
6 1000 mL in 1 BOTTLE This package is contained within the CARTON (50563-195-06)
7 NDC:50563-195-07 4 BOTTLE in 1 CARTON contains a BOTTLE
7 3780 mL in 1 BOTTLE This package is contained within the CARTON (50563-195-07)
8 NDC:50563-195-08 4 BOTTLE in 1 CARTON contains a BOTTLE
8 5000 mL in 1 BOTTLE This package is contained within the CARTON (50563-195-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/03/2020
Labeler — ENCHANTE ACCESSORIES INC. (186050696)
Establishment
Name Address ID/FEI Operations
Hangzhou Huiji Biotechnology Co., Ltd. 526893497 manufacture (50563-195)

Revised: 05/2020 ENCHANTE ACCESSORIES INC.

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