Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol gel
RANG DONG S.P.CA MANUFACTURING — CONSTRUCTION — TRADING 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

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin. 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, and 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 medical help or contact a Poison Control Center right away.

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 medical help or contact a Poison Control Center right away.

Directions

  • Get a sufficient amount of products onto hands.
  • Brisky rub hands together until dry.
  • Supervise children under 6 years old in the use of this product.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label — Principal Display Panel

29.5 mL NDC: 80060-100-01

80060-100-01
(click image for full-size original)

59 mL NDC: 80060-100-02

80060-100-02
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88.5 mL NDC: 80060-100-03

80060-100-03
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118 mL NDC: 80060-100-04

80060-100-04
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236.59 mL NDC: 80060-100-05

80060-100-05
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295 mL NDC: 80060-100-06

80060-100-06
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354 mL NDC: 80060-100-07

80060-100-07
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500 mL NDC: 80060-100-08

80060-100-08
(click image for full-size original)

590 mL NDC: 80060-100-09

80060-100-09
(click image for full-size original)

975 mL NDC: 80060-100-10

80060-100-10
(click image for full-size original)

5000 mL NDC: 80060-100-11

80060-100-11
(click image for full-size original)
HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80060-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 1.45 mL in 100 mL
HYDROGEN PEROXIDE 0.125 mL in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80060-100-01 29.5 mL in 1 BOTTLE None
2 NDC:80060-100-02 59 mL in 1 BOTTLE None
3 NDC:80060-100-03 88.5 mL in 1 BOTTLE None
4 NDC:80060-100-04 118 mL in 1 BOTTLE None
5 NDC:80060-100-05 236.59 mL in 1 BOTTLE None
6 NDC:80060-100-06 295 mL in 1 BOTTLE None
7 NDC:80060-100-07 354 mL in 1 BOTTLE None
8 NDC:80060-100-08 500 mL in 1 BOTTLE None
9 NDC:80060-100-09 590 mL in 1 BOTTLE None
10 NDC:80060-100-10 975 mL in 1 BOTTLE None
11 NDC:80060-100-11 5000 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 08/11/2020
Labeler — RANG DONG S.P.CA MANUFACTURING — CONSTRUCTION — TRADING COMPANY LIMITED (555830568)
Registrant — RANG DONG S.P.CA MANUFACTURING — CONSTRUCTION — TRADING COMPANY LIMITED (555830568)
Establishment
Name Address ID/FEI Operations
RANG DONG S.P.CA MANUFACTURING — CONSTRUCTION — TRADING COMPANY LIMITED 555830568 manufacture (80060-100)

Revised: 10/2020 RANG DONG S.P.CA MANUFACTURING — CONSTRUCTION — TRADING COMPANY LIMITED

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