SAVANNAH FIRST AID ANTISEPTIC MOIST TOWELETTE- benzalkonium chloride patch
JRMI Ltd.

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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Savannah First Aid Antiseptic Moist Towelette

Drug Facts

Active Ingredients

Benzalkonium Chloride, 0.13% w/v......

Purpose

First Aid Antiseptic

Use

Use First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.

Warnings

For external use only.

Do not use

in the eyes or apply over large areas of the body.
longer than 1 week unless directed by a doctor.

Consult a doctor

in case of deep or puncture wounds, animal bites, or serious burns. Stopuse and consult a doctor if the condition persists or gets worse.

Keep out of reach of children.

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

Directions

Clean the affected area
Apply a small amount of this product on the area 1 to 3 times daily
May be covered with a sterile bandage when dry

Inactive ingredients

purified water, sodium bicarbonate

Package Label

Savannah

First Aid

Antiseptic

Moist Towelette

-Benzalkonium Chloride-

FOR EXTERNAL USE ONLY

R & R Enterprises (800) 955-2259

Label

SAVANNAH FIRST AID ANTISEPTIC MOIST TOWELETTE
benzalkonium chloride patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69480-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69480-001-00	1 in 1 POUCH	12/23/2014	08/22/2016
1		1.8 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/23/2014	08/22/2016

Labeler - JRMI Ltd. (189324945)

Name	Address	ID/FEI	Business Operations
Establishment
MC Group Development Ltd		527868588	manufacture(69480-001)

Revised: 10/2016

Document Id: 3fdd5969-a640-6cbc-e054-00144ff8d46c

Set id: 021eefb2-342e-403d-88f4-70c6571e7450

Version: 2

Effective Time: 20161027

JRMI Ltd.