HAND SANITIZER- alcohol gel 
Newacme 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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Hand Sanitizer

Drug Facts

Active ingredients

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses:

For Hand Sanitizing.

Warnings:

For external use only-hands.

Flammable: Keep away from heat and flame.

When using this product

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor

If skin irritation develops.

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

Directions:

Wet hands thoroughly with product and allow to dry without wiping

Other information:

Do not store above 105°F.

Inactive ingredients:

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

Package Labeling:1000ml

Bottle

Package Labeling:2000ml

Bottle2

Package Labeling:3.780ml

Bottle3

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74341-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74341-004-121000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
2NDC:74341-004-132000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
3NDC:74341-004-143780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/20/2020
Labeler - Newacme LLC (117465743)
Establishment
NameAddressID/FEIBusiness Operations
SHANDISHI Biological Technology Co., Ltd.411868994manufacture(74341-004)

Revised: 7/2020
Document Id: aadcc91d-2eb7-1d98-e053-2a95a90a5ecc
Set id: e7709e2c-231f-433c-bdf3-feddca2765b0
Version: 1
Effective Time: 20200720
 
Newacme LLC