51414-915 Antibacterial Hand Sanitizer

antibacterial hand sanitizer by

Drug Labeling and Warnings

antibacterial hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Yuyao Jessie Commodity Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL HAND SANITIZER- alcohol gel 
Yuyao Jessie Commodity 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.

----------

51414-915 Antibacterial Hand Sanitizer

Active Ingredient

Alcohol(62%)

Purpose

Antiseptic

Use

To reduce bacteria on the skin Recommend for repeated use

WARNINGS

For external use onlyhands.
Flammable.
Keep away from head and flame. Stop use and ask a doctor If skin irritation develops. When using this product.

Keep out of eyes. In case of contact with eyes. Flush thoroughly with water. Avoid contact with broken skin. Do not inhale or i ngest.

keep out of reach of children if swallowed,get medical help to contact a poison control center reght away

Keep out of Reach of Children If swallowed, get medical help or contact a Poison Control Right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.For children under 6 use only under adult Supervision.
Not recommended for infants.
Other information:
Do not store above 105°F. May discolor some fabrics. Harmful to wood finishes and plastics.

Inactive ingredients

Aqua, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Triethanolamine, Tocopheryl Acetate.

ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-915
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51414-915-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
2	NDC: 51414-915-02	8 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
3	NDC: 51414-915-03	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
4	NDC: 51414-915-04	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
5	NDC: 51414-915-05	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
6	NDC: 51414-915-06	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
7	NDC: 51414-915-07	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
8	NDC: 51414-915-08	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
9	NDC: 51414-915-09	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023
10	NDC: 51414-915-10	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/25/2023

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-915)

Revised: 2/2023

Document Id: f57df9cc-5a3b-fc4c-e053-2995a90a08c3

34390-5

Set id: f57e3eca-80ec-5a21-e053-2995a90aed31

Version: 1

Effective Time: 20230224