SANITIZER- alcohol spray 
Gandang Kalikasan USA 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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All-Natural Sanitizer Cool Burst

Active Ingredient

Active Ingredient

Ethyl alcohol 60%

Uses:

Uses:

Purpose

Purpose

Antiseptic

Warnings

Warnings

For external use only. Avoid contact with eyes. If contact occurs, rinse with water.

Flammable, keep away from fire or flame.

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

For children under 6, use only under adult supervision. Not recommended for infants.

Directions

Directions:

Shake well.

Spray onto hands and rub thorughly.

Inactive Ingredients

Inactive ingredients

aqua (water), Mentha piperita (peppermint) leaf essential oil, Mentha arvensis (corn mint) leaf essential oil, Aloe barbadensis leaf juice

Principal display panel

Cool Burst drug facts

All-Natural Sanitizer Cool Burst 50ml PDP

SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70143-1002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70143-1002-150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/08/2015
Labeler - Gandang Kalikasan USA Inc. (024656271)

Revised: 12/2018
Document Id: 7e540eb8-e899-7be4-e053-2a91aa0ac08f
Set id: 2673004f-68eb-01df-e054-00144ff8d46c
Version: 3
Effective Time: 20181231
 
Gandang Kalikasan USA Inc.