SCI 80 HAND SANITIZER WIPES- alcohol cloth

SCI 80 Hand Sanitizer Wipes by

Drug Labeling and Warnings

SCI 80 Hand Sanitizer Wipes by is a Otc medication manufactured, distributed, or labeled by Southern Chem Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

e.Fragrance

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 repeat 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

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

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

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, and Fragrance

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SCI 80 HAND SANITIZER WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55549-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55549-007-80	320 mL in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
2	NDC: 55549-007-25	500 mL in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
3	NDC: 55549-007-30	1200 mL in 1 PAIL; Type 0: Not a Combination Product	03/30/2020
4	NDC: 55549-007-40	1600 mL in 1 PAIL; Type 0: Not a Combination Product	08/01/2020
5	NDC: 55549-007-70	2800 mL in 1 PAIL; Type 0: Not a Combination Product	08/01/2020
6	NDC: 55549-007-60	640 mL in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Southern Chem Industries LLC (056025778)

Registrant - Southern Chem Industries LLC (056025778)

Establishment
Name	Address	ID/FEI	Business Operations
Southern Chem Industries LLC		056025778	manufacture(55549-007)