HAND SANITIZER- ethyl alcohol gel 
LYW BIOTECH CO LIMITED GUANGZHOU

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 ingredient

ask doctor

keep out of children

purpose

stop use

when using

inactive ingredient

other info

warning

dasage

indication

package label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81309-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 36 mL  in 100 mL
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) 0.2 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81309-004-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
2NDC:81309-004-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
3NDC:81309-004-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
4NDC:81309-004-04120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
5NDC:81309-004-05250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
6NDC:81309-004-06500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
7NDC:81309-004-071000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
8NDC:81309-004-081500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
9NDC:81309-004-092000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/2021
Labeler - LYW BIOTECH CO LIMITED GUANGZHOU (554530905)
Establishment
NameAddressID/FEIBusiness Operations
LYW BIOTECH CO LIMITED GUANGZHOU554530905manufacture(81309-004)

Revised: 2/2021
Document Id: bbbed9d2-b630-237f-e053-2995a90acd52
Set id: bbbed9d2-b62f-237f-e053-2995a90acd52
Version: 1
Effective Time: 20210220
 
LYW BIOTECH CO LIMITED GUANGZHOU