OTC Medication Information: Hand Sanitizer

HAND SANITIZER- alcohol solution
Taizhou Duorui Biotechnology 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

Antiseptic

Use

Hand sanitizer to help decrease bacteria that potentially can cause disease

For use when soap and water are not available

Warnings

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

Do not use

  • In children less than 2 months of age
  • On open skin wounds

When using this product, keep out of eyes, ears or mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs, these may be signs of a serious condition.

Keep out of reach of children. If swallowed, get immediate medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces
  • Rub hands together until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

Store between 15-30C (59-86F)

Avoid freezing or excessive heat above 40C (104F)

Inactive ingredients

Glycerin, Triethanolamine, Carbomer 940, Aloe Vera Leaf, Alpha Tocopherol, Water

image description
(click image for full-size original)

HAND SANITIZER
alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80800-001
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
CARBOMER 940
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80800-001-01 10 mL in 1 BOTTLE None
2 NDC:80800-001-02 20 mL in 1 BOTTLE None
3 NDC:80800-001-03 30 mL in 1 BOTTLE None
4 NDC:80800-001-04 10 mL in 1 BOTTLE None
5 NDC:80800-001-05 60 mL in 1 BOTTLE None
6 NDC:80800-001-06 100 mL in 1 BOTTLE None
7 NDC:80800-001-07 120 mL in 1 BOTTLE None
8 NDC:80800-001-08 237 mL in 1 BOTTLE None
9 NDC:80800-001-09 250 mL in 1 BOTTLE None
10 NDC:80800-001-10 350 mL in 1 BOTTLE None
11 NDC:80800-001-11 500 mL in 1 BOTTLE None
12 NDC:80800-001-12 1000 mL in 1 BOTTLE None
13 NDC:80800-001-13 3785 mL in 1 BOTTLE None
14 NDC:80800-001-14 53 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 10/09/2020
Labeler — Taizhou Duorui Biotechnology Co., Ltd. (713362289)
Establishment
Name Address ID/FEI Operations
Taizhou Duorui Biotechnology Co., Ltd. 713362289 manufacture (80800-001)

Revised: 10/2020 Taizhou Duorui Biotechnology Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.