ProtectMe Antiseptic Hand Sanitizer: Package Insert and Label Information

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.

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, Aloe Vera Leaf Extract, Propylene Glycol, Fragrance Aloe Vera, Aminomethyl Propanol, Denatonium Benzoate

DISTRIBUTED BY:

LNW PROTECTION LLC

1191 NEWPORT CENTER DR SUITE 103

DEERFIELD BEACH, FL 33442

INFO@PROTECTMESANITIZER.COM

NDC 80029-009-03

PROTECTME

ANTISEPTIC HAND SANITIZER GEL

with Aloe Vera extract

NON-STICKY

QUICK DRYING

KEEP YOUR HANDS CLEAN

75% ALCOHOL FORMULA

8 FL OZ (250 ml)

80029-009 Rev 10-2020
(click image for full-size original)
PROTECTME ANTISEPTIC HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80029-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
DENATONIUM BENZOATE
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
AMINOMETHYLPROPANOL
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80029-009-01 60 mL in 1 BOTTLE None
2 NDC:80029-009-07 860 mL in 1 BOTTLE, PUMP None
3 NDC:80029-009-02 100 mL in 1 BOTTLE None
4 NDC:80029-009-03 250 mL in 1 BOTTLE None
5 NDC:80029-009-06 500 mL in 1 BOTTLE, PUMP None
6 NDC:80029-009-09 3800 mL in 1 JUG None
7 NDC:80029-009-10 5000 mL in 1 JUG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/21/2020
Labeler — LNW Protection LLC (117615415)

Revised: 10/2020 LNW Protection LLC

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