HAND SANITIZER- alcohol gel 
VANILLA SUGAR 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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Active Ingredient(s)

Alcohol 70%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause disease.

Warnings

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

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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, Carbomer, Triethanolamine, Honey Extract, Menthol, Cymbopogon Citratus (Lemongrass) Extract, Anthemis Nobilis (Chamomile) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract.

Package Label - Principal Display Panel

150 mL NDC: 74443-010-15 150 mL Label

500 mL NDC: 74443-010-50 500 mL Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74443-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CYMBOPOGON CITRATUS WHOLE (UNII: 6AE8LT94NG)  
HONEY (UNII: Y9H1V576FH)  
CHAMOMILE (UNII: FGL3685T2X)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74443-010-15150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74443-010-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - VANILLA SUGAR PTY LTD (962303587)
Establishment
NameAddressID/FEIBusiness Operations
Mirfeel Korea695004258manufacture(74443-010)

Revised: 4/2020
Document Id: a242bc59-73f9-d753-e053-2995a90aa5d5
Set id: a242cf7a-8549-6b1f-e053-2995a90a2459
Version: 1
Effective Time: 20200401
 
VANILLA SUGAR PTY LTD