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SCI 70 Hand Sanitizer Gel

Medically reviewed by Drugs.com. Last updated on Aug 27, 2020.

Dosage form: gel
Ingredients: ALCOHOL 80mL in 100mL
Labeler: Southern Chem Industries LLC
NDC Code: 55549-003

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

70 No Fragrance Gel

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) (70%, 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.
  5. Carbomer

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For hand washing to decrease bacteria on the skin - Recommended for repeated use.

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 occurs. These may be signs of a serious condition.

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

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

Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision.

Other information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor some fabrics. Harmful to wood finishes and plastics

Inactive ingredients

glycerin, hydrogen peroxide, carbomer, and purified water USP

Package Label - Principal Display Panel

SCI 70 HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55549-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN1.45 mL  in 100 mL
HYDROGEN PEROXIDE0.125 mL  in 100 mL
WATER 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)4 mL  in 100 mL
Packaging
#Item CodePackage Description
1NDC:55549-003-641892 mL in 1 BOTTLE
2NDC:55549-003-013785 mL in 1 BOTTLE
3NDC:55549-003-0518927 mL in 1 PAIL
4NDC:55549-003-25946353 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
5NDC:55549-003-32946 mL in 1 BOTTLE
6NDC:55549-003-55208198 mL in 1 DRUM
7NDC:55549-003-301135500 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
8NDC:55549-003-0274 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Southern Chem Industries LLC (056025778)
Registrant - Southern Chem Industries LLC (056025778)
Establishment
NameAddressID/FEIOperations
Southern Chem Industries LLC056025778manufacture(55549-003)

 
Southern Chem Industries LLC