Diamond Chemical - Star-San

Star-San by

Drug Labeling and Warnings

Star-San by is a Otc medication manufactured, distributed, or labeled by Diamond Chemical Co Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STAR-SAN- hand sanitizer gel 
Diamond Chemical Co Inc

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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Diamond Chemical - Star-San

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. Isopropyl Alcohol (75%, 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)

Isopropyl Alcohol 70% 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.

Hand sanitizer to help decrease bacteria on the skin

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

• If hands are visibly soiled, was with soap and water then dry hands.
• Wet hands thoroughly with product, especially under the fingernails and allow to dry without rinsing
• Children under 6 years of age should be supervised when using this product

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water (Aqua), PEG-6, AMP-Acrylates / Vinyl Isodecanoate crosspolymer, Aloe Barbadensis Leaf Juice, Fragrance (Parfum).

Star-San Hand Sanitizer

DESCRIPTION

KILLS GERMS FAST
LEAVES HANDS SMOOTH & REFRESHED

This one step sanitizer kills 99.9% of most disease-causing germs within 15 seconds. Use as frequently as wanted and between normal hand washing.

STAR-SAN contains skin conditioners which leaves hands refreshed and sanitized.

STAR-SAN reduces the risk of cross infection without having to use soap and water.

DIRECTIONS

If hands are visibly soiled, wash with soap and water then dry hands.
Wet hands thoroughly with product, especially under the fingernails and allow to dry without rinsing.
Children under 6 years of age should be supervised when using this product.

STAR-SAN ™

GEL INSTANT HAND SANITIZER

USE WITHOUT WATER

NEW & IMPROVED

KEEP OUT OF REACH OF CHILDREN

MANTÉNGASE ALEJADO DEL ALCANCE DE LOS NIÑOS

NET CONTENTS: 1 GALLON

DRUG FACTS

Active Ingredient………...Purpose

Ethyl alcohol 70% v/v…Antimicrobial

USE

Hand sanitizer to help decrease bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product do not use in or near the eyes, In case of contact rinse eye thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

Store below 110°F (43°C)
May discolor certain fabrics or surfaces

Inactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates / Vinyl Isodecanoate crosspolymer, Aloe Barbadensis Leaf Juice, Fragrance (Parfum).

Starco® Chemical

Union Ave & DuBois Street East Rutherford, NJ 07073 (201) 935-4300

STAR-SAN 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72177-186
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
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)	1.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72177-186-23	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020
2	NDC: 72177-186-24	946 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/28/2020

Labeler - Diamond Chemical Co Inc (001381482)

Registrant - Diamond Chemical Co Inc (001381482)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Chemical Co Inc		001381482	manufacture(72177-186)

Revised: 11/2022

Document Id: a0769a09-383d-4181-bf59-c446a0de566f

34390-5

Set id: a97c133f-f199-70a4-e053-2995a90a0bbd

Version: 7

Effective Time: 20221117