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NDC 80716-0299-01 Protective Industrial Products Instant Hand Sanitizer 0.665 mL/mL Details

Protective Industrial Products Instant Hand Sanitizer 0.665 mL/mL

Protective Industrial Products Instant Hand Sanitizer is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Protective Industrial Products. The primary component is ALCOHOL.

Product Information

NDC	80716-0299
Product ID	80716-299_aa3546d6-b775-40cd-b44d-23dfaea20e24
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	Protective Industrial Products Instant Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	0.665
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	Protective Industrial Products
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 80716-0299-01 (80716029901)

Pricing Information	N/A
NDC Package Code	80716-299-01
Billing NDC	80716029901
Package	59.1 mL in 1 BOTTLE (80716-299-01)
Marketing Start Date	2020-10-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 62f10f90-eba2-4f14-99c1-833cf7178571 Details

Active Ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

for handwashing to decrease bacteria on skin whenever soap and water is not readily available.

Warnings

For external use only. Flammable, keep away from flame.

Do not use in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and persists for more than 72 hours.

Keep out of reach of children

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

Directions

wet hands & wrists thoroughly with product and allow to dry without wiping
children under 6 years of age should be supervised when using this product

Inactive ingredients

aloe vera, fragrance, purified triethanolamine

Principal Display Panel - 2.0 FL OZ Bottle Label

PIP®

PROTECTIVE INDUSTRIAL PRODUCTS

INSTANT

HAND

SANITIZER

SPRAY

KILLS 99.99% OF GERMS

ENRICHED WITH ALOE VERA

2.0 FL OZ (59.1 ML)

299-34417/S

Principal Display Panel - 2.0 FL OZ Bottle Label

Principal Display Panel - 4.0 FL OZ Bottle Label

PIP®

PROTECTIVE INDUSTRIAL PRODUCTS

INSTANT

HAND

SANITIZER

SPRAY

KILLS 99.99% OF GERMS

ENRICHED WITH ALOE VERA

4.0 FL OZ (118.3 ML)

299-34418/S

Principal Display Panel - 4.0 FL OZ Bottle Label

INGREDIENTS AND APPEARANCE

PROTECTIVE INDUSTRIAL PRODUCTS INSTANT HAND SANITIZER

alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80716-299
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.665 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80716-299-01	59.1 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2020
2	NDC:80716-299-02	118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/07/2020

Labeler - Protective Industrial Products (131639874)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(80716-299)

Revised: 10/2020

Document Id: aa3546d6-b775-40cd-b44d-23dfaea20e24

Set id: 62f10f90-eba2-4f14-99c1-833cf7178571

Version: 2

Effective Time: 20201006