DANS ANTI-BACTERIAL BAR OAT / AVENA- benzalkonium chloride soap

Dans Anti-bacterial Bar by

Drug Labeling and Warnings

Dans Anti-bacterial Bar by is a Otc medication manufactured, distributed, or labeled by HADA International S.A, HADA International S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.1%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Use for washing to decrease bacteria on the skin

WARNINGS

Warnings

For external use only

WHEN USING

When using this product do not use in or near the eyes, in case of eye contact, flush with water

STOP USE

Stop use and ask a doctor if irritation or redness develop

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

Inactive ingredients Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Chloride, Avena Sativa (Oat) Bran, Fragrance, Etidronic Acid, Titanium Dioxide, Tetrasodium EDTA, Hydrolyzed Collagen, Coumarin, Geraniol, Linalool, Yellow #10 (CI 47005), Red No. 4 (CI 14700).

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Manufactured by:

HADA INTERNATIONAL, S.A.

Zona Franca La Cayena Km 8 LT7MZ8

Barranquilla, Columbia

Made in Columbia

Calls USA: +1 (787)7856822

PRINCIPAL DISPLAY PANEL

Hada Dans®
ANTIBACTERIAL BAR SOAP
OAT / AVENA
With Collagen
NET WT 4.4 OZ (125g)

INGREDIENTS AND APPEARANCE

DANS ANTI-BACTERIAL BAR  OAT / AVENA
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42377-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 3500 MW) (UNII: 5WE8P977RQ)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
GLYCERIN (UNII: PDC6A3C0OX)
OAT BRAN (UNII: KQX236OK4U)
WATER (UNII: 059QF0KO0R)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
GERANIOL (UNII: L837108USY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COUMARIN (UNII: A4VZ22K1WT)
ETIDRONIC ACID (UNII: M2F465ROXU)
EDETATE SODIUM (UNII: MP1J8420LU)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42377-010-04	125 g in 1 BOX; Type 0: Not a Combination Product	03/06/2020
2	NDC: 42377-010-14	3 in 1 BOX	03/06/2020
2		125 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	03/06/2020

Labeler - HADA International S.A (882405152)

Establishment
Name	Address	ID/FEI	Business Operations
HADA International S.A.		882405152	manufacture(42377-010)