RAW ANTISEPTIC HAND SANITIZER WIPES: Package Insert and Label Information

RAW ANTISEPTIC HAND SANITIZER WIPES- alcohol cloth
Zhuji Jianhe Paper 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.

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial.

Use

Hand sanitizer to help reduce bacteria on skin

Warnings

■ External use, not oral. Keep out of children’s reach.

■ Flammable, keep away from fire and flame.

■ Use with caution if allergic to alcohol.

When using this product

Avoid contacting face, eyes and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

Stop use and ask doctor if

■ Irritation or redness occurs.

Keep out of reach of children.If swallowed, get medical help or contact poison control center right away.

Directions

Wet hands thoroughly with product and allow to dry.

Inactive ingredients

Purified Water, Glycerol, Aloe Vera

Do not use

on children less than 2 months of age
on open skin wounds

Other information

■ Store below 43°C (110°F)

■ Keep sealed after use

SPL UNCLASSIFIED SECTION

Product Use:

Hold and grasp the barrel with both hands then turn the lid counter-clockwise. Take out the wet towel bag, tear the package parallel from the tear hole, pull towel through the centre hole of the barrel lid. Make sure to close lid between uses.

Rawoffice.com

MADE IN CHINA

Package Label — Principal Display Panel

90 pcs wetwipes NDC:75163-090-01

90 cloth label
(click image for full-size original)
90 cloth back label
(click image for full-size original)

RAW ANTISEPTIC HAND SANITIZER WIPES
ethyl alcohol cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75163-090
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
ALOE VERA LEAF
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75163-090-01 90 PACKAGE in 1 CANISTER contains a PACKAGE
1 5.4 mL in 1 PACKAGE This package is contained within the CANISTER (75163-090-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — Zhuji Jianhe Paper Co., Ltd (554529241)
Registrant — Zhuji Jianhe Paper Co., Ltd (554529241)
Establishment
Name Address ID/FEI Operations
Zhuji Jianhe Paper Co., Ltd 554529241 manufacture (75163-090)

Revised: 09/2020 Zhuji Jianhe Paper Co., Ltd

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