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NDC 74110-0001-03 Protect Hand Sanitizer 70 mL/100mL Details

Protect Hand Sanitizer 70 mL/100mL

Protect Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Brite. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	74110-0001
Product ID	74110-001_d4ebdff9-91cb-2cd9-e053-2a95a90a12d0
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	Protect Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Dr. Brite
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 74110-0001-03 (74110000103)

Pricing Information	N/A
NDC Package Code	74110-001-03
Billing NDC	74110000103
Package	100 mL in 1 BOTTLE, PUMP (74110-001-03)
Marketing Start Date	2020-03-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a21a8935-ea33-8568-e053-2a95a90ae7f6 Details

Active Ingredient(s)

Isopropyl Alcohol 70% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.
When hand wahing, water & soap are not available
recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame. Do not apply around eyes.

Do not use

in children less than 2 months of age
on open skin wounds

SPL UNCLASSIFIED SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

pump or spray a small amount into your palms, and rub lightly into hands
let air dry

Other information

store at 20C (68 to 77F)
may discolor fabrics

Inactive ingredients

vegtable glycerin, aloe barbadensis (alow vera) juice, hydrogen peroxide, citrus aurantium dulcis (orange) peel oil, azadirachta indica (neem) extract, rosemarinus officinalis (rosemary) oil, carbomer

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PROTECT HAND SANITIZER

isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74110-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
ROSEMARY OIL (UNII: 8LGU7VM393)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
XANTHAN GUM (UNII: TTV12P4NEE)
LEMON OIL (UNII: I9GRO824LL)
GRAPEFRUIT OIL (UNII: YR377U58W9)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
ORANGE OIL (UNII: AKN3KSD11B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74110-001-01	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
2	NDC:74110-001-02	7 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020	04/15/2020
3	NDC:74110-001-03	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

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

Labeler - Dr. Brite (079902543)

Name	Address	ID/FEI	Business Operations
Establishment
Dr. Brite		079902543	manufacture(74110-001)

Revised: 1/2022

Document Id: d4ebdff9-91cb-2cd9-e053-2a95a90a12d0

Set id: a21a8935-ea33-8568-e053-2a95a90ae7f6

Version: 3

Effective Time: 20220106

Search by Drug Name or NDC

NDC 74110-0001-03 Protect Hand Sanitizer 70 mL/100mL Details

Protect Hand Sanitizer 70 mL/100mL

Product Information

Package

Package Images

NDC 74110-0001-03 (74110000103)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a21a8935-ea33-8568-e053-2a95a90ae7f6 Details

Active Ingredient(s)

Purpose

Use

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

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