TINTURA DE ARNICA- isopropyl alcohol and arnica extract solution

Tintura de Arnica by

Drug Labeling and Warnings

Tintura de Arnica by is a Otc medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, World Perfume, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                   Purpose

Isopropyl Alcohol 63-69% by Volume................... Antiseptic

PURPOSE

Use

May help prevent skin infection in

• minor cuts
• scrapes 
• burns
• bruises

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.

INDICATIONS & USAGE

Antiseptic

For External Use Only

DOSAGE & ADMINISTRATION

Directions

• clean the affected area
• and dry thoroughly. Apply a thin layer 1 to 3 times daily.
• May be covered with a sterile bandage, let dry first.

WARNINGS

Warnings For external use only

Avoid Contact with eyes.

When using this product

• do not use on irritated skin, in or near eyes or mocous membranes, on wounds or damaged skin, if prone to allergic reaction
• Fatal if swallowed.

Stop use and ask a doctor if condition persists or gets worse

INACTIVE INGREDIENT

Inactive Ingredients Arnica Extract, Isopropyl Alcohol, Deionized Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTURA DE ARNICA 
isopropyl alcohol and arnica extract solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.13 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-129-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2015

Labeler - Dannso Corp./d.b.a. Essential Products (059741071)

Registrant - Dannso Corp./d.b.a. Essential Products (059741071)

Establishment
Name	Address	ID/FEI	Business Operations
Dannso Corp./d.b.a. Essential Products		059741071	LABEL(70242-129)

Establishment
Name	Address	ID/FEI	Business Operations
World Perfume, Inc		101312044	MANUFACTURE(70242-129)