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 INGREDIENTS:

ETHYL ALCOHOL 75%

PURPOSE

ANTISEPTIC

USES

HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN. STOP USE AND SEEK MEDICAL ADVICE IF IRRITATION OR REDNESS DEVELOPS, OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

KEEP OUT OF REACH OF CHILDREN.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

DISPENSE ONE PUMP OF SANITIZER ON TO HANDS AND RUB TOGETHER UNTIL DRY. USE AS NEEDED. FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION. NOT RECOMMENDED FOR INFANTS.

OTHER INFO

STORE BELOW 110 (DEGREES FAHRENHEIT). MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES.

INACTIVE INGREDIENTS

WATER (AQUA), CARBOMER, TRIETHANOLAMINE.

Package Label

HAND SANITIZER (60ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

60ml e (2.0 fl.oz.)

NDC: 74658-001-01 60ml bottle label

Package Label

HAND SANITIZER (60ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

60ml e (2.0 fl.oz.)

NDC: 74658-001-02 60ml Tube Label

Package Label

HAND SANITIZER (70ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

70ml e (2.36 fl.oz.)

NDC: 74658-001-03 70ml label

Package Label

100ml e (3.4 fl.oz.)

NDC: 74658-001-04

100ml label

Package Label

HAND SANITIZER (120ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

120ml e (4.0 fl.oz.)

NDC: 74658-001-05 120ml label

Package Label

236ml e (8 fl.oz.)

NDC: 74658-001-06

236ml label

Package Label

HAND SANITIZER (250ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

250ml e (8.5 fl.oz.)

NDC: 74658-001-07 250ml label

Package Label

HAND SANITIZER (260ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

260ml e (8.8 fl.oz.)

NDC: 74658-001-08 260ml label

Package Label

HAND SANITIZER (290ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

290ml e (9.8 fl.oz.)

NDC: 74658-001-09 290ml label

Package Label

HAND SANITIZER (300ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

300ml e (10.2 fl.oz.)

NDC: 74658-001-10 300ml label

Package Label

500ml e (17 fl.oz.)

NDC: 74658-001-11

500ml label

Package Label

HAND SANITIZER (950ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

950ml e (32.3 fl.oz.)

NDC: 74658-001-12 950ml label

Package Label

HAND SANITIZER (1000ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

1000ml e (34 fl.oz.)

NDC: 74658-001-13 1000ml label

Package Label

HAND SANITIZER (2000ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

2000ml e (68 fl.oz.)

NDC: 74658-001-14 2000ml label

Package Label

HAND SANITIZER (30ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

30ml e (1.0 fl.oz.)

NDC: 74658-001-15 30ml label

Package Label

HAND SANITIZER (40ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

40ml e (1.35 fl.oz.)

NDC: 74658-001-16 40ml label

Package Label

HAND SANITIZER (50ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

50ml e (1.7 fl.oz.)

NDC: 74658-001-17 50ml label

Package Label

HAND SANITIZER (3785ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

3785ml e (128.68 fl.oz.)

NDC: 74658-001-18 3785ml label

Package Label

HAND SANITIZER (5000ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

5000ml e (170 fl.oz.)

NDC: 74658-001-19 5000ml label

Package Label

HAND SANITIZER (236ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

236ml e (8 fl.oz.) 236ml pump label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74658-001
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
TROLAMINE (UNII: 9O3K93S3TK) 0.22 g  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.4 g  in 100 mL
WATER (UNII: 059QF0KO0R) 22.19 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74658-001-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
2NDC:74658-001-0370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
3NDC:74658-001-04100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
4NDC:74658-001-05120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
5NDC:74658-001-06236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
6NDC:74658-001-07250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
7NDC:74658-001-08260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
8NDC:74658-001-09290 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
9NDC:74658-001-10300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
10NDC:74658-001-11500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
11NDC:74658-001-12950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
12NDC:74658-001-131000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
13NDC:74658-001-142000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
14NDC:74658-001-0260 mL in 1 TUBE; Type 0: Not a Combination Product03/18/2020
15NDC:74658-001-1530 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
16NDC:74658-001-1750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
17NDC:74658-001-1640 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
18NDC:74658-001-183785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
19NDC:74658-001-195000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
20NDC:74658-001-20236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/18/2020
Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU XUELEI COSMETIC CO.,LTD.526885026manufacture(74658-001) , pack(74658-001) , label(74658-001)

Revised: 11/2021
Document Id: d0012e60-249f-cdfb-e053-2995a90a606d
Set id: a2a922e9-caf2-bd77-e053-2995a90a1941
Version: 6
Effective Time: 20211104
 
GUANGZHOU XUELEI COSMETIC CO.,LTD.