ProtectMe Hand Sanitizer Gel

ProtectMe Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

ProtectMe Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by LNW Protection LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROTECTME ANTISEPTIC HAND SANITIZER- alcohol gel 
LNW Protection LLC

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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ProtectMe Hand Sanitizer Gel

Drug Facts

Active ingredient

Alcohol 75%

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin
• recommended for repeated use

Warnings

For external use only.

Flammable. Keep away from fire or flame

When using this product keep away from eyes. In case of contact, flush eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develop or persist 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 thoroughly with product
• allow to dry without wiping
• supervise children under 6 years old
• not recommended for infants

Other information

• store between 15°-30°C (59°-86°F).
• do not store above 40ºC (104ºF)
• may discolor some fabrics

Inactive Ingredients

Water, Carbomer, Aminomethylpropanol, Propylene Glycol, Denatonium benzoate

DISTRIBUTED BY:

LNW PROTECTION LLC

1191 NEWPORT CENTER DR SUITE 103

DEERFIELD BEACH, FL 33442

INFO@PROTECTMESANITIZER.COM

PROTECTME

ANTISEPTIC HAND SANITIZER GEL

NON-STICKY

UNSCENTED

QUICK DRYING

KEEP YOUR HANDS CLEAN

75% ALCOHOL FORMULA

15 FL OZ (460ml)

PROTECTME ANTISEPTIC HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80029-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80029-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2020	11/01/2021
2	NDC: 80029-001-05	460 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/19/2020	11/01/2021
3	NDC: 80029-001-07	860 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/19/2020	11/01/2021
4	NDC: 80029-001-04	400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/19/2020	11/01/2021
5	NDC: 80029-001-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2020	11/01/2021
6	NDC: 80029-001-06	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/19/2020	11/01/2021
7	NDC: 80029-001-09	3800 mL in 1 JUG; Type 0: Not a Combination Product	08/19/2020	11/01/2021
8	NDC: 80029-001-10	5000 mL in 1 JUG; Type 0: Not a Combination Product	08/19/2020	11/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/19/2020	11/01/2021

Labeler - LNW Protection LLC (117615415)

Revised: 11/2021

Document Id: cfbbcbc5-4551-edf3-e053-2995a90a18e2

34390-5

Set id: ac9ff926-c3de-ad5c-e053-2a95a90a0ad4

Version: 2

Effective Time: 20211101