HAND SANITIZER- hand sanitizer gel 
GUANGZHOU XUELEI COSMETIC 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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HAND SANITIZER

Active Ingredient

Alcohol（75% v//v）

Purpose

Antiseptic

Uses

help decrease bacteria on the hands

Warnings

For external use only.

Flammable. Keep away from fire or flame. Do not store in car.

Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately

Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.

If irritation develops, discontinue use and consult a doctor.

Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.

Directions

Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.

Other Information

May discolor fabrics or surfaces. Store below 95 °F (35 ° C).

Inactive ingredients

Carbomer, Denatonium Benzoate, Purified Water USP, Tert-butyl Alcohol, Triethanolamine.

50ml NDC: 74658-010-01

50ml label

60ml NDC: 74658-010-02

60ml label

236ml NDC: 74658-010-03

236ml label

250ml NDC: 74658-010-04

250ml label

260ml NDC: 74658-010-05

260ml label

300ml NDC: 74658-010-06

300ml label

500ml NDC: 74658-010-07

500ml label

1000ml NDC: 74658-010-08

1000ml label

5000ml NDC: 74658-010-09

5000ml label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74658-010
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
WATER (UNII: 059QF0KO0R) 22.1937 g  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.0809 g  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.4 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.22 g  in 100 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 0.0004 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74658-010-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
2NDC:74658-010-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
3NDC:74658-010-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
4NDC:74658-010-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
5NDC:74658-010-05260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
6NDC:74658-010-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
7NDC:74658-010-07500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/02/2020
8NDC:74658-010-081000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/02/2020
9NDC:74658-010-095000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/02/2020
Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU XUELEI COSMETIC CO.,LTD.526885026manufacture(74658-010) , pack(74658-010) , label(74658-010)

Revised: 11/2021
Document Id: d0578f8d-9a2b-6a6d-e053-2a95a90aef93
Set id: ae4991a8-b72f-fc95-e053-2995a90a2352
Version: 5
Effective Time: 20211109
 
GUANGZHOU XUELEI COSMETIC CO.,LTD.