HAND SANITIZER- alcohol gel 
NingBo Huize 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.

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71011-005 HAND SANITIZER

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

Decreases bacteria on hands

Warning

For external use only.
Flammable: Keep away from flame or high heat
When using this product keep out of eyes.In case of contact flush eyes with water. Avoid contact with broken skin.

Stop use and ask a doctor if irritation or redness develop.

Keep out of reach of children

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

Directions

Rub hands thoroughly with product and allow to dry.

INACTIVE INGREDIENT

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, FD&C BLUE NO.1

12

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71011-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
Product Characteristics
Coloryellow, blue, purple, brown, red, green, orangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71011-005-015 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
2NDC:71011-005-028 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
3NDC:71011-005-0310 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
4NDC:71011-005-0415 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
5NDC:71011-005-0520 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2016
6NDC:71011-005-0630 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2016
7NDC:71011-005-0750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
8NDC:71011-005-0860 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
9NDC:71011-005-0980 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
10NDC:71011-005-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
11NDC:71011-005-11150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
12NDC:71011-005-12200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
13NDC:71011-005-13250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
14NDC:71011-005-14300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
15NDC:71011-005-15400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
16NDC:71011-005-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
17NDC:71011-005-17600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
18NDC:71011-005-18700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
19NDC:71011-005-19800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
20NDC:71011-005-20900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
21NDC:71011-005-211000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
22NDC:71011-005-222000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
23NDC:71011-005-235 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
24NDC:71011-005-248 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
25NDC:71011-005-2525 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
26NDC:71011-005-2615 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
27NDC:71011-005-2720 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
28NDC:71011-005-2840 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2016
Labeler - NingBo Huize Commodity Co.,Ltd. (544434795)
Establishment
NameAddressID/FEIBusiness Operations
NingBo Huize Commodity Co.,Ltd.544434795manufacture(71011-005)

Revised: 8/2018
Document Id: 741a45d3-e34e-26d1-e053-2991aa0a7bb6
Set id: 741a45d3-e34d-26d1-e053-2991aa0a7bb6
Version: 1
Effective Time: 20180823
 
NingBo Huize Commodity Co.,Ltd.