OTC Medication Information: Hand Sanitizer

HAND SANITIZER- 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.

active ingredient
(click image for full-size original)

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 Type HUMAN OTC DRUG Item Code (Source) NDC:81309-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE 0.4 mL in 100 mL
CARBOMER 940 0.4 mL in 100 mL
WATER 36 mL in 100 mL
PAEONIA SUFFRUTICOSA ROOT 0.2 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81309-004-01 30 mL in 1 BOTTLE, PLASTIC None
2 NDC:81309-004-02 60 mL in 1 BOTTLE, PLASTIC None
3 NDC:81309-004-03 100 mL in 1 BOTTLE, PLASTIC None
4 NDC:81309-004-04 120 mL in 1 BOTTLE, PLASTIC None
5 NDC:81309-004-05 250 mL in 1 BOTTLE, PLASTIC None
6 NDC:81309-004-06 500 mL in 1 BOTTLE, PLASTIC None
7 NDC:81309-004-07 1000 mL in 1 BOTTLE, PLASTIC None
8 NDC:81309-004-08 1500 mL in 1 BOTTLE, PLASTIC None
9 NDC:81309-004-09 2000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 02/01/2021
Labeler — LYW BIOTECH CO LIMITED GUANGZHOU (554530905)
Establishment
Name Address ID/FEI Operations
LYW BIOTECH CO LIMITED GUANGZHOU 554530905 manufacture (81309-004)

Revised: 02/2021 LYW BIOTECH CO LIMITED GUANGZHOU

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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