SCI 80 HAND SANITIZER- alcohol liquid 
Southern Chem Industries 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.

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80%

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

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

Warnings

for external use only - Flammable. Keep away from heat and flame.

Do not use

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 serious condition. Keep out of reach of children. If swallowed, get medical help of 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

Other information

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

Inactive ingredients

Package.Label Principal Display Panelglycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Package Label Principal Display Panel946 mL NDC: 55549-001-32

or

1892 mL NDC: 55549-001-64

or

3785 mL NDC: 55549-001-01

or

118927 mL NDC: 55549-001-05

or

208198 mL NDC: 55549-001-55

or

946353 mL NDC: 55549-001-25

or

1135500 mL NDC: 55549-001-30

SCI 80 HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55549-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55549-001-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:55549-001-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
3NDC:55549-001-0518927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:55549-001-641892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:55549-001-25946353 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
6NDC:55549-001-301135500 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
7NDC:55549-001-55208198 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
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/FEIBusiness Operations
Southern Chem Industries LLC056025778manufacture(55549-001)

Revised: 6/2020
Document Id: a75d1855-434d-7181-e053-2a95a90a817e
Set id: a36aa584-dfb9-3223-e053-2995a90a9417
Version: 4
Effective Time: 20200605
 
Southern Chem Industries LLC