HAND SANITIZER- alcohol gel 
GuangDong B.C. Biotech 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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B.C., Hand Sanitizer, Gel, 70% Alcohol, 236mL

Active Ingredient(s)

Ethanol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

Flammable. For external use only. 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

Inactive ingredients

Water, Olive Oil PEG-7 Esters, Acrylates/C10-30 Alkyl, Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract

Package Label - Principal Display Panel

236

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74738-1103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL165.2 mL  in 236 mL
Inactive Ingredients
Ingredient NameStrength
PEG-7 STEARATE (UNII: VCX261B12R) 4.72 mL  in 236 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 1.18 mL  in 236 mL
WATER (UNII: 059QF0KO0R) 63.956 mL  in 236 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.236 mL  in 236 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.708 mL  in 236 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74738-1103-624 in 1 CARTON04/21/2020
1NDC:74738-1103-3236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/21/2020
Labeler - GuangDong B.C. Biotech Co., Ltd. (403932907)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
GuangDong B.C. Biotech Co., Ltd.403932907manufacture(74738-1103) , label(74738-1103)

Revised: 4/2020
Document Id: a3b36940-4410-3fa3-e053-2995a90abc12
Set id: a3b36940-440f-3fa3-e053-2995a90abc12
Version: 1
Effective Time: 20200421
 
GuangDong B.C. Biotech Co., Ltd.