Celtic Suds Alcohol Free Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by BioSyn Inc, Toll Solutions, Higley Industries, Ins. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- benzalkonium chloride liquid 
BioSyn 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.

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Celtic Suds Alcohol Free Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial and First Aid Antiseptic

Uses:

For hand sanitizing to decrease bacteria on the skin. As a wound antiseptic to help prevent bacterial contamination in cuts, burns, scrapes, lacerations, and skin infections.

Warnings:

For External Use Only

When Using This Product

avoid contact with eyes. In case of eye contact, flush eyes with water

Discontinue Use if

irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children

If swallowed, get medical help, or contact a poison control center right away.

Directions:

• Pump onto hands as needed. Rub briskly until dry.
• Apply to wounds 3 times per day after cleaning. Allow to dry. May be bandaged once dry.

Inactive Ingredients

Colalipid C, Green Tea Leaf Extract, Hydroxyethyl Cellulose, Sodium Bicarbonate, Water

Principal Dislpay Panel

1 gallon NDC: 79832-301-80

16oz NDC: 79832-301-16

8oz NDC: 79832-301-08

HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79832-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79832-301-80	3.78 L in 1 JUG; Type 0: Not a Combination Product	01/08/2021
2	NDC: 79832-301-16	0.473176 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2021
3	NDC: 79832-301-08	0.236588 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/08/2021	08/01/2023

Labeler - BioSyn Inc (079797906)

Establishment
Name	Address	ID/FEI	Business Operations
Toll Solutions		004854914	manufacture(79832-301)

Establishment
Name	Address	ID/FEI	Business Operations
Higley Industries, Ins		005467626	manufacture(79832-301)

Revised: 1/2023

Document Id: f1f5dc41-a6ea-a694-e053-2995a90a1eb3

34390-5

Set id: b865dc50-ea2d-09e8-e053-2995a90aeb1b

Version: 4

Effective Time: 20230110

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