OTC Medication Information: Hand Sanitizer

HAND SANITIZER- alcohol gel
TRANG LY PHARMA TRADE COMPANY LIMITED

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.

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antimicrobial

Use

Dry Hand Sanitizer helps prevent the development of bacteria on the skin.

It moisturizes and softens the hand skin with the sweet fragrance.

Warnings

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

Do not use

  • for children under 36 months.


Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.


For children: need to be supervised by adults when using it.

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

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 in dry and cool place

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Keep our of reach of children

Package Label — Principal Display Panel

100 mL NDC: 90098-100-01

90098-100-01
(click image for full-size original)

250 mL NDC: 90098-100-02

90098-100-02
(click image for full-size original)

500 mL NDC: 90098-100-03

90098-100-03
(click image for full-size original)

1000 mL NDC: 90098-100-04

90098-100-04
(click image for full-size original)

2000 mL NDC: 90098-100-05

90098-100-05
(click image for full-size original)

10000 mL NDC: 90098-100-06

90098-100-06
(click image for full-size original)

20000 mL NDC: 90098-100-07

90098-100-07
(click image for full-size original)

59 mL NDC: 90098-100-08

90098-100-08
(click image for full-size original)

1 Gallon NDC: 90098-100-09

90098-100-09
(click image for full-size original)
HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:90098-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 72 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER 22 mL in 100 mL
MINT 6 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:90098-100-01 100 mL in 1 BOTTLE None
2 NDC:90098-100-02 250 mL in 1 BOTTLE None
3 NDC:90098-100-03 500 mL in 1 BOTTLE None
4 NDC:90098-100-04 1000 mL in 1 BOTTLE None
5 NDC:90098-100-05 2000 mL in 1 BOTTLE None
6 NDC:90098-100-06 10000 mL in 1 BOTTLE None
7 NDC:90098-100-07 20000 mL in 1 BOTTLE None
8 NDC:90098-100-08 59 mL in 1 BOTTLE None
9 NDC:90098-100-09 20000 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 — TRANG LY PHARMA TRADE COMPANY LIMITED (555252970)
Registrant — TRANG LY PHARMA TRADE COMPANY LIMITED (555252970)
Establishment
Name Address ID/FEI Operations
TRANG LY PHARMA TRADE COMPANY LIMITED 555252970 manufacture (90098-100)

Revised: 10/2020 TRANG LY PHARMA TRADE COMPANY LIMITED

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.

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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.

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