ANTI-BAC HAND SANITIZER- alcohol gel 
SCENT THEORY PRODUCTS 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.

----------

BORN BASIC.  ANTI-BAC HAND SANITIZER (70% ETHANOL)

ACTIVE INGREDIENT

ETHYL ALCOHOL 70%

PURPOSE

ANTISEPTIC

USES

  • DECREASES BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE
  • RECOMMENDED FOR REPEATED USE

WARNINGS

For external use only: hands

Flammable. Keep away from fire or 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

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

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

DIRECTIONS

  • WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING.
  • FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.
  • NOT RECOMMENDED FOR INFANTS.

OTHER INFORMATION

  • DO NOT STORE ABOVE 105°F
  • MAY DISCOLOR SOME FABRICS
  • HARMFUL TO WOOD FINISHES AND PLASTICS

INACTIVE INGREDIENTS

WATER, CARBOMER, TRIETHANOLAMINE, GLYCERINE

01b LBL_HandSanitizer

ANTI-BAC HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76891-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76891-104-111000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/11/2020
2NDC:76891-104-171000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
3NDC:76891-104-181000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2020
4NDC:76891-104-12500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
5NDC:76891-104-13236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
6NDC:76891-104-14280 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
7NDC:76891-104-152011 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
8NDC:76891-104-163667 mL in 1 JUG; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/17/2019
Labeler - SCENT THEORY PRODUCTS LLC (101216246)

Revised: 7/2020
Document Id: 4bdd9d38-3a63-427c-8654-68c959cc6da7
Set id: a584e226-1263-45a3-b622-3f6d7bd80c60
Version: 5
Effective Time: 20200701
 
SCENT THEORY PRODUCTS LLC