BNC HAND SANITIZER ANTISEPTIC- alcohol gel 
BNC KOREA 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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Active Ingredient

Alcohol 80% v/v.

Purpose

Antiseptic

Uses

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.

Directions

Other information

Store between 15-300C (59-860F)
Avoid freezing and excessive heat above 400C (1040F)

Inactive ingredients

Aloe vera leaf, Butylene glycol, Carbomer, Glycerin, 1,2-hexanediol, Purified water USP, Trolamine

Questions? CALL 213-462-9955

Package Label - Principal Display Panel

Label 100 mL

Label1

Label 300 mL

Label2

Label 500 mL

Label3

BNC HAND SANITIZER ANTISEPTIC 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78419-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78419-002-01100 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2020
2NDC:78419-002-02300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
3NDC:78419-002-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - BNC KOREA CO., Ltd. (694074732)
Establishment
NameAddressID/FEIBusiness Operations
BNC KOREA CO., Ltd.694074732manufacture(78419-002)

Revised: 6/2020
Document Id: 4f7db08b-fe5f-4947-b733-4b42742d9ad8
Set id: a2903f30-3f3c-471b-8d98-344539f1ae42
Version: 1
Effective Time: 20200601
 
BNC KOREA CO., Ltd.