BAIMIANQIANSHU HAND SANITIZER- alcohol gel 
Zhejiang Tianbo Daily Necessities 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 75%

Purpose

Antimicrobial

Use

Use to clean hands to reduce bacteria.

Warnings

For external use only. Discontinue use if irritation or allergy occurs. Flammable, keep away from heat and flame.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

In children less than 2 months of age.

Avoid contact with eyes, mouth and wounds. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use

Stop use and ask a doctor if irritation or allergy occurs.

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.

Inactive ingredients

Water,

Carbomer,

Glycerin,

Propanediol,

Triethanolamine

Storage

Store between 15-30C (15-30F). In a cool dry place. Prevent direct sunlight.

Label

Label

BAIMIANQIANSHU HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79901-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPANEDIOL (UNII: 5965N8W85T)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79901-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
2NDC:79901-001-0280 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
3NDC:79901-001-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
4NDC:79901-001-04200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2020
5NDC:79901-001-05300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2020
6NDC:79901-001-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2020
7NDC:79901-001-071000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2020
8NDC:79901-001-083785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/28/2020
Labeler - Zhejiang Tianbo Daily Necessities Co.Ltd (554539553)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Tianbo Daily Necessities Co.Ltd554539553manufacture(79901-001)

Revised: 7/2020
Document Id: ab784403-0f63-37e6-e053-2a95a90a9026
Set id: ab784403-0f62-37e6-e053-2a95a90a9026
Version: 1
Effective Time: 20200727
 
Zhejiang Tianbo Daily Necessities Co.Ltd