P B Pure Antibacterial Hand Sanitizer Sweet Pea Scented: Package Insert and Label Information

P B PURE ANTIBACTERIAL HAND SANITIZER SWEET PEA 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, red 33

Package Labeling:

P B PURE ANTIBACTERIAL HAND SANITIZER SWEET PEA SCENTED alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80684-002 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 D&C RED NO. 33

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:80684-002-01 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.