ANGEL OF MINE FOAMING HAND SANITIZER- benzalkonium chloride liquid 
Greenbrier International, 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.

----------

angel of mine Foaming Hand Sanitizer

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

to decrease bacteria on the skin

Warnings

For external use only, hands only

When using this product

■ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water ■ avoid contact with broken skin

Stop use and ask a doctor if

■ irritation or redness develops ■ 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

Inactive ingredients

water, cetrimonium chloride, disodium cocoamphodiacetate, PEG-12 dimethicone, citrus reticulata X C sinensis peel extract, tocopheryl acetate, methylchloroisithiazolinone, methylisothiazolinone

Package Label

package label

ANGEL OF MINE  FOAMING HAND SANITIZER
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
WATER (UNII: 059QF0KO0R)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
TANGERINE PEEL (UNII: JU3D414057)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1450-8236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/17/2020
Labeler - Greenbrier International, Inc (610322518)
Establishment
NameAddressID/FEIBusiness Operations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil533151022manufacture(33992-1450)

Revised: 1/2021
Document Id: b8f42133-645f-3668-e053-2995a90a1805
Set id: a3bf282b-a4b7-464d-e053-2a95a90a000d
Version: 2
Effective Time: 20210115
 
Greenbrier International, Inc