Hand Sanitizer Wipes: Package Insert and Label Information

HAND SANITIZER WIPES- benzalkonium chloride cloth
KYNC Design 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.

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

Benzalkonium Chloride 0.125% (CAS NO: 68424-85-1). Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Hand sanitizing wipes help remove bacteria from hands and kill 99.99% of germs. Removes dirt to help with health and cleanliness.

Warnings

Use on hands only.

Do not use

Do not use if you are allergic to any of the ingeredients.

Do not use in or near the eyes. If contact occurs, rinse with plenty of water. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical advice/attention.

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

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children.

Directions

To Open Package: Flip open dispensing cap. Locate wipe at center of roll and pull through small openning in lid. For best results dispense wipes at an angle. Wet hands thoroughly with product and allow to dry. When finished, snap lid cap shut to retain moisture. Discard wipe in trash receptacle after use. Do not flush.

Other information

n/a

Inactive ingredients

Water(Aqua), Ethanol, Decyl Glucoside, Glycerine, Aloe Vera Extract, D-Panthenol, Fragrance (Perfume)

Package Label — Principal Display Panel

110 mL NDC: 76557-001-01

110ML
(click image for full-size original)

245 mL NDC: 76557-001-01

245ML
(click image for full-size original)

HAND SANITIZER WIPES
juniper clean cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76557-001
Route of Administration CUTANEOUS, TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.125 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
CLOVE
DECYL GLUCOSIDE
DEXPANTHENOL
ALOE VERA LEAF
GLYCERIN
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76557-001-02 245 mg in 1 CANISTER None
2 NDC:76557-001-01 110 mg in 1 CANISTER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/10/2020
Labeler — KYNC Design LLC (039933298)

Revised: 08/2020 KYNC Design LLC

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