P B Pure Antibacterial Hand Sanitizer Cucumber Melon Scented: Package Insert and Label Information

P B PURE ANTIBACTERIAL HAND SANITIZER CUCUMBER MELON SCENTED- alcohol gel
FOURSTAR GROUP USA, INC.

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

Ethyl Alcohol, 65% v/v

Purpose

Antimicrobial

Uses

hand sanitizer to help reduce bacteria on skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

in or near the eyes In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation, excessive redness or rash develops.

Keep out of reach of children.

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

Directions

Put a dime sized drop onto hands and rub together briskly until dry.

Other information

Store below 110°F (43°C)

Inactive ingredients

water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, blue 1, yellow 5

Package Labeling:

Bottle
(click image for full-size original)

P B PURE ANTIBACTERIAL HAND SANITIZER CUCUMBER MELON SCENTED
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80684-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.65 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80684-000-01 29 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/24/2020
Labeler — FOURSTAR GROUP USA, INC. (140099503)

Revised: 10/2020 FOURSTAR GROUP USA, INC.

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