FDA Label for Rugby Arthritis Pain Relieving Topical Analgesic
View Indications, Usage & Precautions
Rugby Arthritis Pain Relieving Topical Analgesic Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
Distributed by: Rugby Laboratories
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Active Ingredient
Capsaicin 0.075%
Purpose
Topical Analgesic
Uses
temporarily relieves minor aches and pains of muscles and joints due to:
♦ simple backache♦ arthritis♦ strains♦ sprains
Warnings
For external use only
Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.
Do Not Use
♦ on wounds or damaged skin♦ if you are allergic to capsicum or chili peppers
When Using This Product
♦ you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.♦ avoid contact with eyes, lips, nose and mucous membranes♦ do not tightly wrap or bandage the treated area♦ do not apply heat to the treated area immediately before or after use
Stop And Ask A Doctor If
♦ condition worsens or does not improve after regular use♦ severe burning persists or blistering occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Directions
Adults and children 18 years of age and older:
♦ apply a thin film of cream to affected area and gently rub in until fully absorbed♦ unless treating hands, wash hands thoroughly with soap and water immediately after application♦ for best results, apply 3 to 4 times daily.
Children under 18 years: ask a doctor
Other Information
Store at room temperature 15° - 30°C (59°F – 86°F).
Inactive Ingredients
benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, petrolatum, sorbitol, water
Questions Or Comments?
1-800-645-2158
Principal Display Panel - 57 G Tube Carton
NDC 0536-1118-25
Rugby ®
COMPARE TO
ZOSTRIX® HP
ACTIVE INGREDIENT*
HIGH POTENCY
ARTHRITIS PAIN RELIEVING CREAM
0.075% CAPSAICIN TOPICAL ANALGESIC
Odor Free Formula • Clinically Tested Active Ingredient
Net Wt 2 oz (57 g)
* Please review the disclaimer below.