Pain Relief: Homeopathic Product Information

PAIN RELIEF- arnica montana flower salve
Sierra Sage Herbs LLC

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.

Purpose

External Analgesic

OTC Active Ingredients

Organic Arnica montana (Arnica) 1X (HPUS)

Indications & Usage

■ temporarily reief of minor aches and pains of muscles and joints associated with ■ arthritis ■ bruises ■ sprains ■ scrapes ■ strains ■ simple backache ■ sore muscles

Warnings

Warnings

For external use only.

■ Avoid contact with eyes.
■ Do not use on ■ on deep wounds ■ animal bites ■ serious burns
■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

Keep Out of Reach of Children.

Storage and Handling

Store at room temperature.

Dosage & Administration

Adults and children 2 years of age and older: Apply to affected area
not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Menthol, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Cinnamomum Zeylanicum Bark (Cinnamon) Oil.

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Pain Relief Principal Panel-Back
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PAIN RELIEF
arnica, menthol crystals, cinnamon, peppermint, ginger, rosemary salve
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70994-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA FLOWER (ARNICA MONTANA FLOWER) ARNICA MONTANA FLOWER 1 [hp_X] in 17 g
Inactive Ingredients
Ingredient Name Strength
OLIVE OIL
YELLOW WAX
SUNFLOWER OIL
MENTHOL
ROSEMARY OIL
CINNAMON OIL
GINGER OIL
MENTHA PIPERITA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70994-102-04 17 g in 1 TUBE None
2 NDC:70994-102-09 1 CAN in 1 BOX contains a CAN (70994-102-01)
2 NDC:70994-102-01 19.8 g in 1 CAN This package is contained within the BOX (70994-102-09)
3 NDC:70994-102-10 1 CAN in 1 BOX contains a CAN (70994-102-02)
3 NDC:70994-102-02 51.7 g in 1 CAN This package is contained within the BOX (70994-102-10)
4 NDC:70994-102-08 113.4 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/31/2016
Labeler — Sierra Sage Herbs LLC (006970452)

Revised: 01/2021 Sierra Sage Herbs LLC

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