HAND SANITISER: Package Insert and Label Information

HAND SANITISER- alcohol gel
Jinhua City Wellmae Cosmetics 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)

Alcohol 75%

Purpose

Antiseptic

Use

Reduce bacteria on hands.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

Stop using this product and ask a doctor if: irritation or redness develops and lasts.

When using this product:Avoid contact with eyes. If contact occurs, rinse with water.

Stop using this product and ask a doctor if: irritation or redness develops and lasts.

In case of accidental ingestion, cet med al help or contact a Poison Control Center immediatelly

Directions

  • Wet hands thoroughly and rub together until dry. Not recommended for infants

Other information

Do not store above105℉

May discolor some fabrics.Harmful to wood finishes and plastics.

Inactive ingredients

Aqua,Propyleone Glycol, Glycerine,Carbopol 940,Triethanolamine

Package Label — Principal Display Panel

50
(click image for full-size original)
100
(click image for full-size original)
250
(click image for full-size original)
600
(click image for full-size original)

HAND SANITISER
hand sanitiser gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75427-003
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
TROLAMINE
GLYCERIN
PROPYLENE GLYCOL
CARBOMER 940
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75427-003-01 60 mL in 1 BOTTLE None
2 NDC:75427-003-02 100 mL in 1 BOTTLE None
3 NDC:75427-003-03 250 mL in 1 BOTTLE None
4 NDC:75427-003-04 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — Jinhua City Wellmae Cosmetics Co., Ltd. (543459963)
Establishment
Name Address ID/FEI Operations
Jinhua City Wellmae Cosmetics Co., Ltd. 543459963 manufacture (75427-003), label (75427-003)

Revised: 05/2020 Jinhua City Wellmae Cosmetics Co., Ltd.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.