SHIERJIE 75% ALCOHOL WIPES- shierjie 75% alcohol wipes cloth 
Shenzhen Shierjie Biotech 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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43116-018
SHIERJIE 75% Alcohol Wipes


Active Ingredient

Ethyl Alcohol 75%

Purpose

Antimicrobial

Uses

To help reduce bacteria on skin.

Warnings

Flammable. Keep away from fire or flame, For external use only.When using this product,do not use in or near the eyes.In case of contact,rinse eyes thoroughly with water.Stop use and ask doctor if irritation or rash appears and lasts,Keep out of reach for children if swallowed,get medical help of contact a Poison Control Center right away.

Directions

Put enough product in your palm to cover hands and rub hands together until dry.

Children under 6 years of age should be supervised when using this product.


Other information

Store below 110°(43°C)

May discolor certain fabrics or surfaces

Inactive ingredients

Water(Aqua),Non-woven

Package Label - Principal Display Panel

10P(43116-018-01)40P(43116-018-05)50P(43116-018-02)1P(43116-018-04)80P(43116-018-03)

SHIERJIE 75% ALCOHOL WIPES 
shierjie 75% alcohol wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43116-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43116-018-0110 in 1 PACKAGE; Type 0: Not a Combination Product03/31/2020
2NDC:43116-018-0250 in 1 PACKAGE; Type 0: Not a Combination Product03/31/2020
3NDC:43116-018-0380 in 1 PACKAGE; Type 0: Not a Combination Product03/31/2020
4NDC:43116-018-041 in 1 PACKAGE; Type 0: Not a Combination Product03/31/2020
5NDC:43116-018-0540 in 1 PACKAGE; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2020
Labeler - Shenzhen Shierjie Biotech Co .,LTD (547610261)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Shierjie Biotech Co .,LTD547610261manufacture(43116-018)

Revised: 9/2020
Document Id: af55eb18-e53f-cb3c-e053-2995a90a14f1
Set id: a833d07a-dda5-d830-e053-2a95a90ac63e
Version: 3
Effective Time: 20200915
 
Shenzhen Shierjie Biotech Co .,LTD