HAND SANITIZER- alcohol gel 
Dongguan City Dexu Toys Co.,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

Active Ingredients

Ethyl Alcohol 75% Purpose: Antibactirial

Purpose

Antibacterial

Uses

for handwashing to decrease bacteria on the skin

Warnings

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

do not use in eyes.In case of contact with eye rinse with water

when using this product do not use in eyes.In case of contact with eye rinse with water

Stop use and ask a doctor if

irritation or redness develop and persist

Keep out of reach of children. If swallowed, get medical help promiptly

Directions

Wet hands thoroughly with product and allow to dry without wiping

Other information

Store under 105℉

Inactive ingredients

ALOE BARBADENSIS LEAF,carbomer,dimethicone,triisopropanolamine,water

Package Label - Principal Display Panel

50mL NDC: 78048-001-01 label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78048-001
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78048-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2020
Labeler - Dongguan City Dexu Toys Co.,Ltd (403382659)
Establishment
NameAddressID/FEIBusiness Operations
Dongguan City Dexu Toys Co.,Ltd403382659manufacture(78048-001)

Revised: 5/2020
Document Id: a60cf263-6b3b-4f85-e053-2995a90a2b9f
Set id: a60d0b61-d166-0fad-e053-2a95a90a6707
Version: 1
Effective Time: 20200519
 
Dongguan City Dexu Toys Co.,Ltd