HAND SANITIZER- alcohol gel 
ABSOLUTE MARKETING, 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.

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Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic PDP 78389-003-99 A

Purpose

Antiseptic PDP 78389-003-99 B

Use

PDP 78389-003-99 CHand Sanitizer to reduce bacterial organisms on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Avoid contact with eyes. If contact occurs, flush eyes throughly with water.


Stop use and ask a doctor if irritation or rash develops and persists. T

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Stop use and ask a doctor if irritation or rash develops and persists.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Water, Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Triethanolamine

Package Label - Principal Display Panel

PDP 78389-003-99

BW PL Label 78389-003-99 PDP

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78389-003
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
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) 0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.65 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78389-003-993780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/12/2020
Labeler - ABSOLUTE MARKETING, INC. (117483207)
Registrant - ABSOLUTE MARKETING, INC. (117483207)
Establishment
NameAddressID/FEIBusiness Operations
Beaming White LLC019910700manufacture(78389-003)

Revised: 6/2020
Document Id: a75ae4d6-21d4-54a4-e053-2a95a90af11a
Set id: a75ae4d6-21d3-54a4-e053-2a95a90af11a
Version: 1
Effective Time: 20200605
 
ABSOLUTE MARKETING, INC.