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NDC 72177-0281-76 Performance Plus 70 mL/100mL Details

Performance Plus 70 mL/100mL

Performance Plus is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Diamond Chemical Co Inc. The primary component is ALCOHOL.

Product Information

NDC	72177-0281
Product ID	72177-281_7ad37702-51f8-46bd-b762-8ba2860ec065
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Performance Plus
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hand Sanitizer
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Diamond Chemical Co Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72177-0281-76 (72177028176)

Pricing Information	N/A
NDC Package Code	72177-281-76
Billing NDC	72177028176
Package	3780 mL in 1 CONTAINER (72177-281-76)
Marketing Start Date	2020-08-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 54615c7d-0f95-4635-b7d0-96c528f83686 Details

SPL UNCLASSIFIED SECTION

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:

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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PERFORMANCE PLUS

hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72177-281
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)	28.5 mL in 100 mL

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

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

Labeler - Diamond Chemical Co Inc (001381482)

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

Revised: 11/2022

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

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

Version: 5

Effective Time: 20221117

Search by Drug Name or NDC

NDC 72177-0281-76 Performance Plus 70 mL/100mL Details

Performance Plus 70 mL/100mL

Product Information

Package

Package Images

NDC 72177-0281-76 (72177028176)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 54615c7d-0f95-4635-b7d0-96c528f83686 Details

SPL UNCLASSIFIED SECTION

Active Ingredient

Purpose

Use

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other Information

Inactive Ingredients

Performance Plus Gel Hand Sanitizer

INGREDIENTS AND APPEARANCE

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