BOTANIKA AUSTRALIA ALOE VERA ANTI BACTERIAL HAND SANITIZER- alcohol gel 
COGNESCENTI PTY. LTD.

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 ingredient

SD Alcohol 40-B 75% v/v

Purpose

Antiseptic

USE

  • hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from fire and flame.

When using this product

avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation and redness develops.

Keep out of reach of children.

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

Directions

Other information:

Inactive ingredients

Purified Water (Aqua), Cross Polymer, Triethanolamine, Parfum (Fragrance), Citronellol, Linalool, Lilial, Benzyl Salicylate, Hexyl Cinnamic Aldehyde, Ceranil, Cumarin, Hydroxycitronellal, Amyl Cinnamic Aldehyde, Eugenol Cinnamyl Alcohol, Eugenol Cinnamyl Alcohol, Methyl Ionone, Benzyl Benzoate, Benzyl Alcohol, Citral, Iso Eugenol, Limonene

package

label image

BOTANIKA AUSTRALIA ALOE VERA ANTI BACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79978-009
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
BENZYL BENZOATE (UNII: N863NB338G)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CITRAL (UNII: T7EU0O9VPP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79978-009-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/28/2020
Labeler - COGNESCENTI PTY. LTD. (745278551)
Establishment
NameAddressID/FEIBusiness Operations
COGNESCENTI PTY. LTD.745278551manufacture(79978-009)

Revised: 8/2020
Document Id: 486f729b-d512-44e4-8cfd-95820cc3779e
Set id: 619e589c-a377-4047-9160-af49e3042b8f
Version: 1
Effective Time: 20200828
 
COGNESCENTI PTY. LTD.