Performance Plus Gel Hand Sanitizer

Performance Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

PERFORMANCE PLUS- 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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Performance Plus Gel Hand Sanitizer

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

Active Ingredient…... Ethyl alcohol 70% v/v

Purpose

Purpose………………………….…. Antimicrobial

Use

• Hand sanitize to help decrease bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not use

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

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.

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.

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).

Performance Plus Gel Hand Sanitizer

KILLS GERMS FAST LEAVES HANDS SMOOTH & REFRESHED This one step sanitizer kills most disease-causing germs within seconds. Use as frequently as wanted and between normal hand washing. GEL HAND SANITIZER contains skin conditioners which leaves hands refreshed and sanitized. GEL HAND SANITIZER 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. KEEP OUT OF REACH OF CHILDREN MANTÉNGASE ALEJADO DEL ALOANCE DE LOS NIÑOS Distributed By: RJ Schinner Co. Inc. N89W14700 Patrita Drive, Menomonee Falls, WI 53051 (800) 234-1460

PP-28176 PERFORMANCE™ PLUS GEL HAND SANITIZER WITH ALOE DESINFECTANTE DE MANOS DE GEL CON ALOE 1 US gal (3.78L) NDC: 72177-281-76

DRUG FACTS Active Ingredient…... Ethyl alcohol 70% v/v Purpose………………………….…. Antimicrobial USE Hand sanitize 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). MADE IN THE USA Exceptional performance + GREAT VALUE TSR 18621 8  20524  01256  9

PERFORMANCE PLUS 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72177-281
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)	28.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72177-281-76	3780 mL in 1 CONTAINER; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

Labeler - Diamond Chemical Co Inc (001381482)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Chemical Co Inc		001381482	manufacture(72177-281)

Revised: 11/2022

Document Id: 7ad37702-51f8-46bd-b762-8ba2860ec065

34390-5

Set id: 54615c7d-0f95-4635-b7d0-96c528f83686

Version: 5

Effective Time: 20221117