ALCOHOL WIPES- alcohol wipes cloth 
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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ALCOHOL WIPES

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.

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.

DIRECTIONS

1、OPEN THE BARREL CAP;

2、RIVE THE SEAL;

3、PULL OUT THE WET TISSUE TOWEL THROUGH SMALL OPENING;

4、COVER THE LIP;

5、RUB THOROUGHLY OVER ALL SURFACES OF BOTH HANDS WITH THE WET WIPES;

6、ALLOW TO DRY WITHOUT WIPING;

7、DISPOSE OF WIPES IN TRASH AFTER USE. DOT NOT FLUSH.

OTHER INFORMATION

STORE IN ROOM TEMPERATURE. AVOID DIRECT SUNLIGHT.

SHELF LIFE: 2 YEARS

INACTIVE INGREDIENTS

WATER (AQUA), TERT-BUTYL ALCOHOL, DENATONIUM BENZOATE

1 WIPES, NDC: 74658-013-01

1wipes label

75 WIPES, NDC: 74658-013-02

75wipes label

80 WIPES, NDC: 74658-013-03

80wipes label

100 WIPES, NDC: 74658-013-04

100wipes label

120 WIPES, NDC: 74658-013-05

120wipes label

130 WIPES, NDC: 74658-013-06

130wipes label

150 WIPES, NDC: 74658-013-07

150wipes label

180 WIPES, NDC: 74658-013-08

180wipes label

200 WIPES, NDC: 74658-013-09

200wipes label

ALCOHOL WIPES 
alcohol wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74658-013
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
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
WATER (UNII: 059QF0KO0R)  
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74658-013-011 in 1 BAG10/10/2020
14.3 mL in 1 PATCH; Type 0: Not a Combination Product
2NDC:74658-013-0275 in 1 BOTTLE10/10/2020
24.3 mL in 1 PATCH; Type 0: Not a Combination Product
3NDC:74658-013-0380 in 1 BOTTLE10/10/2020
34.3 mL in 1 PATCH; Type 0: Not a Combination Product
4NDC:74658-013-04100 in 1 BOTTLE10/10/2020
44.3 mL in 1 PATCH; Type 0: Not a Combination Product
5NDC:74658-013-05120 in 1 BOTTLE10/10/2020
54.3 mL in 1 PATCH; Type 0: Not a Combination Product
6NDC:74658-013-06130 in 1 BOTTLE10/10/2020
64.3 mL in 1 PATCH; Type 0: Not a Combination Product
7NDC:74658-013-07150 in 1 BOTTLE10/10/2020
74.3 mL in 1 PATCH; Type 0: Not a Combination Product
8NDC:74658-013-08180 in 1 BOTTLE10/10/2020
84.3 mL in 1 PATCH; Type 0: Not a Combination Product
9NDC:74658-013-09200 in 1 BOTTLE10/10/2020
94.3 mL in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/10/2020
Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU XUELEI COSMETIC CO.,LTD.526885026manufacture(74658-013) , label(74658-013) , pack(74658-013)

Revised: 11/2021
Document Id: d06b3394-3d0a-8044-e053-2a95a90a537c
Set id: b69f2109-0e1d-9924-e053-2995a90a9b50
Version: 2
Effective Time: 20211110
 
GUANGZHOU XUELEI COSMETIC CO.,LTD.