BATURALS HAND SANITIZER- ethyl alcohol gel 
Guangdong Authenmole Biotech 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.

----------

BATURALS HAND SANITIZER

Drug Facts

Active ingredient

Ethyl alcohol 75%

Purpose

Antiseptic

Use ▪ Helps decrease bacteria on skin. ▪ Recommended for repeated use.

Warnings Flammable. Keep away from fire or flame. For external use only

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops.

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions ▪ Place enough product in your palm to thoroughly cover your hands

▪ Rub hands together briskly until dry

▪ Children under 6 years of age use only under adult supervisions

Other information ▪ Store at 77°F (25°C) ▪ May discolor fabrics

Inactive ingredients

Water, Propylene, Glycerin, Fragrance, Carbomer, Triethanolamine, Tocopheryl Acetate

Kills 99.9% of Germs

Refreshing Gel

Packaging

image description

BATURALS HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74218-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE (UNII: AUG1H506LY)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74218-001-5050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/07/2020
Labeler - Guangdong Authenmole Biotech Inc. (559966091)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Authenmole Biotech Inc.559966091manufacture(74218-001)

Revised: 4/2020
Document Id: 551693dc-28dc-41ca-95fa-a7fd14774710
Set id: 60451ede-86f8-4e03-bbba-c1f10cbb88fa
Version: 1
Effective Time: 20200407
 
Guangdong Authenmole Biotech Inc.