HAND SANITIZER- hand sanitizer gel 
Virgin Scent 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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74642-007 473ml 62.5%

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 62.5% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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. 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.

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(AQUA), GLYCERIN, FRAGRANCE/PARFUM, CARBOMER,AMINOMETHYL PROPANOL, PROPANEDIOL,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL , ALOE BARBADENSIS (ALOE VERA) LEAF JUICE , PROPYLENE GLYCOL, TOCOPHERYL ACETATE , HELIANTHUS ANNUUS (SUNFLOWER)SEED OIL, ACTINIDIA CHINENSIS ( KIWI) FRUIT EXTRACT, FRAGARIA CHILOENSIS (STRAWBERRY) FRUIT EXTRACT ,PUNICA GRANATUM (POMEGRANATE) FRUIT EXTRACT, VACCINIUM ANGUSTIFOLIUM (BLUEBERRY)FRUIT EXTRACT, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT

Package Label - Principal Display Panel

473 mL in 1 bottle NDC: 74642-007-01

473 ml label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74642-007
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL295.625 mL  in 473 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CRANBERRY JUICE (UNII: Y74M3X3345)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
KIWI FRUIT (UNII: 71ES77LGJC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPANEDIOL (UNII: 5965N8W85T)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
JOJOBA OIL (UNII: 724GKU717M)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
STRAWBERRY JUICE (UNII: U8NS58UGW0)  
POMEGRANATE JUICE (UNII: 99S671U9KB)  
LOWBUSH BLUEBERRY JUICE (UNII: 834067J0NY)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code artnaturals
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74642-007-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Virgin Scent Inc. (034474058)
Registrant - ZHEJIANG SHUNAN INDUSTRY&TRADE CO.,LTD (528198838)
Establishment
NameAddressID/FEIBusiness Operations
ZHEJIANG SHUNAN INDUSTRY & TRADE CO., LTD528198838manufacture(74642-007) , label(74642-007)

Revised: 6/2020
Document Id: a8b744a2-f504-6f6a-e053-2a95a90ac8ef
Set id: a8b71598-fcf1-4087-e053-2a95a90a9d10
Version: 1
Effective Time: 20200622
 
Virgin Scent Inc.