HAND SANITIZER- alcohol gel 
Leads (China) Biotechnology 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.

----------

Hand Sanitizer

ACTIVE INGREDIENT(S)

Ethyl Alcohol 70%-75% 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.

For external use only. Flammable. Keep away from heat or flame

DO NOT USE

in children less than 2 months of age
on open skin wounds

WHEN USING

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.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

Water(aqua), Glycerin, Carbomer, Aminomethyl propanol, Fragrance(parfum), Aloe barbadensis leaf extract, May contains FD & C Blue No.1(CI 42090).

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

56 mL NDC: 77969-004-01

56 ml label

56 ml label56 ml label500 mL NDC: 77969-004-02

500 ml label

500 ml label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77969-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 28.0199 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E) 0.35 mL  in 100 mL
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.18 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
PIGMENT BLUE 1 (UNII: 4SBE571RQF) 0.0001 mL  in 100 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.4 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77969-004-0156 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
2NDC:77969-004-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/06/2020
Labeler - Leads (China) Biotechnology Co., Ltd. (416037073)
Registrant - Leads (China) Biotechnology Co., Ltd. (416037073)
Establishment
NameAddressID/FEIBusiness Operations
Leads (China) Biotechnology Co., Ltd.416037073manufacture(77969-004)

Revised: 9/2020
Document Id: af42852f-8b0b-5e69-e053-2995a90a757d
Set id: aae102ab-a715-3c25-e053-2995a90ac72b
Version: 3
Effective Time: 20200914
 
Leads (China) Biotechnology Co., Ltd.