PROTECT HAND SANITIZER- isopropyl alcohol gel

Protect Hand Sanitizer by

Drug Labeling and Warnings

Protect Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dr. Brite. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

WHEN USING

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

STOP USE

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Dr. Brite (079902543)

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