OTC Medication Information: Hand Sanitizer

HAND SANITIZER- alcohol liquid
Caribbean Distillers LLC

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.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce 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, 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

  • 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 and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

55 gallon Drum Package Label — Principal Display Panel

208.198 L NDC: 74092-280-04

208.198 L Drum
(click image for full-size original)

265 gallon Tote

1003.13 L Drum
(click image for full-size original)

1.5 ltr Plastic

1.5L PLastic
(click image for full-size original)

1.75L Plastic

1.75 L Plastic
(click image for full-size original)

1L Plastic

1L Plastic
(click image for full-size original)

HAND SANITIZER
alcohol antiseptic 80% hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74092-280
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 8000 L in 10000 L
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 145 L in 10000 L
HYDROGEN PEROXIDE 4.17 L in 10000 L
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74092-280-01 0.75 L in 1 BOTTLE, GLASS None
2 NDC:74092-280-02 1 L in 1 BOTTLE, PLASTIC None
3 NDC:74092-280-03 18.927 L in 1 PAIL None
4 NDC:74092-280-04 208.198 L in 1 DRUM None
5 NDC:74092-280-05 1003.13 L in 1 DRUM None
6 NDC:74092-280-13 1 BAG in 1 BOX contains a BAG (74092-280-06)
6 NDC:74092-280-06 3 L in 1 BAG This package is contained within the BOX (74092-280-13)
7 NDC:74092-280-07 1.75 L in 1 BOTTLE, PLASTIC None
8 NDC:74092-280-09 1.5 L in 1 BOTTLE, PLASTIC None
9 NDC:74092-280-11 18.925 L in 1 BAG None
10 NDC:74092-280-00 1 BAG in 1 BOX contains a BAG (74092-280-12)
10 NDC:74092-280-12 3 L in 1 BAG This package is contained within the BOX (74092-280-00)
11 NDC:74092-280-15 1 BAG in 1 BOX contains a BAG (74092-280-14)
11 NDC:74092-280-14 3 L in 1 BAG This package is contained within the BOX (74092-280-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/02/2020
Labeler — Caribbean Distillers LLC (968074257)
Registrant — Caribbean Distillers LLC (968074257)
Establishment
Name Address ID/FEI Operations
Caribbean Distillers LLC 968074257 manufacture (74092-280)

Revised: 07/2020 Caribbean Distillers LLC

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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