OTC Medication Information: BabyGanics Alcohol-Free Foaming Hand Sanitizer Mandarin

BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN- benzalkonium chloride liquid
KAS Direct LLC dba BabyGanics

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

Benzalkonium chloride 0.12%

Purpose

Antimicrobial

Uses

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

Warnings

For external use only

When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops, or if condition lasts 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

• pump a small amount of foam into palm of hand
• rub thoroughly over all surfaces of both hands
• rub hands together briskly until dry

Inactive ingredients

water, propanediol, cocamidopropylamine oxide, cetrimonium chloride, pyrus malus (apple) fruit extract, aloe barbadensis leaf juice 1, calendula officinalis flower extract 1, chamomilla recutita (matricaria) flower extract 1, olea europaea (olive) leaf extract 1, glycerin, citric acid, caprylyl/capryl glucoside, citrus aurantium dulcis (orange) peel extract, citrus reticulata (mandarin orange) peel oil, triethyl citrate, citrus grandis (grapefruit) peel oil, glycine soya oil, tocopherol

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1

Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.

PRINCIPAL DISPLAY PANEL — 249 mL Bottle Label

babyganics_®

alcohol-free foaming
hand sanitizer

mandarin

kills 99.9% of bacteria*

dermatologist tested

Discover which of our ingredients
are certified organic on the back panel.

8.45 FL OZ (249 mL)

1137403

BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN benzalkonium chloride liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-4001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.12 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER PROPANEDIOL COCAMIDOPROPYLAMINE OXIDE CETRIMONIUM CHLORIDE APPLE ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER MATRICARIA CHAMOMILLA WHOLE OLIVE OIL GLYCERIN CITRIC ACID MONOHYDRATE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE ORANGE PEEL MANDARIN OIL TRIETHYL CITRATE CITRUS MAXIMA FRUIT RIND OIL SOYBEAN OIL TOCOPHEROL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59062-4001-2 250 mL in 1 BOTTLE, PUMP None 2 NDC:59062-4001-5 50 mL in 1 BOTTLE, PUMP None 3 NDC:59062-4001-1 473 mL in 1 BOTTLE, PUMP None 4 NDC:59062-4001-3 2 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP (59062-4001-5) 4 NDC:59062-4001-5 50 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (59062-4001-3)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 06/01/2022

Labeler — KAS Direct LLC dba BabyGanics (002764605)

Revised: 06/2022 KAS Direct LLC dba BabyGanics