046 MedSpa Antibacterial Soap

MedSpa Antibacterial Bar by

Drug Labeling and Warnings

MedSpa Antibacterial Bar by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDSPA ANTIBACTERIAL BAR- triclosan soap 
Medline Industries, 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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046 MedSpa Antibacterial Soap

Active ingredient

Triclosan 0.3%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on the skin

Warnings

For external use only.

Do not use

this product on infants under 6 months of age.

When using this product

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

Stop use and ask a doctor if

• irritation and redness develops.

Keep out of reach of children.

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

Directions

• Wet bar with water
• Lather vigorously and wash skin
• Rinse and dry thoroughly

Other information

• Protect from freezing and avoid excessive heat.

Inactive ingredients

Calcium Carbonate, Fragrance, Glycerine, Sodium Chloride, Sodium Palmate, Water.

Package/Label Principal Display Panel

Principal Display panel

NDC: 53329-046-68

MedSpa

Antibacterial

Bar soap

Contents: 200

NET WT. 1.25 oz (35 g) each

Drug Facts and Side Panel

MEDSPA ANTIBACTERIAL BAR 
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PALMATE (UNII: S0A6004K3Z)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-046-68	200 in 1 CARTON	03/26/2015	01/01/2017
1		35 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/26/2015	01/01/2017

Labeler - Medline Industries, Inc. (025460908)

Revised: 12/2019

Document Id: 9a9d47d7-9f3e-d393-e053-2a95a90a0a18

34390-5

Set id: 6290e040-d143-4915-a69e-1145e1350aff

Version: 2

Effective Time: 20191226