SCI 80 HAND SANITIZER WIPES- alcohol cloth 
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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70 No Fragrance Wipes

  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.

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 repeat use.

Warnings

For external use only. Flammable. Keep away from heat or 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 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. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age whould be supervised when using this product.

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Package label Principle Display Panel

SCI 80 HAND SANITIZER WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55549-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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:55549-006-80320 mL in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
2NDC:55549-006-25500 mL in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
3NDC:55549-006-301200 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
4NDC:55549-006-401600 mL in 1 PAIL; Type 0: Not a Combination Product08/01/2020
5NDC:55549-006-702800 mL in 1 PAIL; Type 0: Not a Combination Product08/01/2020
6NDC:55549-006-60640 mL in 1 CANISTER; 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(55549-006)

Revised: 8/2020
Document Id: ad67efef-0ed4-2c9d-e053-2995a90a4253
Set id: acaefecc-f6ee-fbaf-e053-2995a90a380d
Version: 2
Effective Time: 20200821
 
Southern Chem Industries LLC