BAC-D ANTIBACTERIAL WOUND AND SKIN CARE- benzalkonium chloride spray
RDM Products, 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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BAC-D Antibacterial Wound and Skin care

Active ingredient

Benzalkonium chloride 0.13 %

Purpose

First aid Product

Keep out of reach of children.

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

Uses

First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes, burns and post-surgical incision sites.

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

Directions for use

Clean the affected area
Spray a small amount of this product on the area 1 to 3 times a day.
May be covered with a sterile bandage
If bandaged let dry first

Inactive ingredients

Ionized water, Carbamide

Made in the U.S.A

Manufactured for

RDM Products Inc.

910-491-7371

PO Box 35003

Fayetteville, NC 28303

www.BAC-D.com

Packaging

AnimalSpray

BAC-D ANTIBACTERIAL WOUND AND SKIN CARE
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69082-500
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 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69082-500-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/12/2014

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

Labeler - RDM Products, Inc (034340230)

Name	Address	ID/FEI	Business Operations
Establishment
RDM Products, Inc		034340230	manufacture(69082-500)