Ouch Aid Arnica Compress: Homeopathic Product Information

OUCH AID ARNICA COMPRESS- arnica montana tincture
Dr. Hauschka SkinCare Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Active Ingredient: Arnica montana

Inactive Ingredients: Alcohol, Purified Water

first aid for sprains, strains and bruises

Contains 25% alcohol by volume. Do not apply to broken skin. Avoid mucous membranes and the area around the eyes. Wash your hands thoroughly after use. Do not use if you are allergic to plants in the daisy family (Compositae).

Keep out of reach of children.

Do not apply to nipples if you are nursing. Do not use during pregnancy.

If symptoms do not improve within 3-4 days, consult a doctor.

Uses: For temporary relief of pain and swelling associated with sprains, strains, bruises and general muscular discomfort.

Directions: Apply topically to affected area as a compress. See insert for further information. Follow with Dr. Hauschka Arnica Bump and Bruise Relief.

Made in Germany

Distributed By:
Dr. Hauschka Skin Care, Inc.
59 North Street
Hatfield MA 01038, USA

In the US contact: 800-247-9907
www.drhauschka.com

Manufactured by:
WALA Heilmittel GmbH
73085 Bad Boll
Germany

Ouch! Aid

Arnica Compress

first aid for sprains, strains and bruises

Homeopathic

Ouch Aid Label
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Insert Page 1
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Insert Page 2
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OUCH AID ARNICA COMPRESS arnica montana tincture
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51979-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 4 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51979-001-01 1 TINCTURE (PACKAGE) in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/10/2010
Labeler — Dr. Hauschka SkinCare Inc. (618629877)
Registrant — Dr. Hauschka SkinCare Inc. (618629877)
Establishment
Name Address ID/FEI Operations
Dr. Hauschka SkinCare Inc. 618629877 relabel
Establishment
Name Address ID/FEI Operations
WALA Heilmittel GmbH 316144880 manufacture

Revised: 09/2010 Dr. Hauschka SkinCare Inc.

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