FDA Label for Rugby Lidocaine
View Indications, Usage & Precautions
Rugby Lidocaine Product Label
The following document was submitted to the FDA by the labeler of this product Rugby. 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
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RUGBY® LABORATORIES
17177 N Laurel Park Drive,
Suite 233
Livonia, MI 48152
Active Ingredient
Lidocaine 4%
Purpose
Topical analgesic
Use
for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
Warnings
For external use only.
Avoid contact with eyes.
Not for prolonged use.
Otc - Do Not Use
Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occurs again within a few days
- rash or irritation develops, persists, or increases
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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: 800-222-1222.
Directions
Adults and children 12 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 doctor
Other Information
- store at 15 to 30°C (59 to 86°F)
- Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Inactive Ingredients
aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid
Questions Or Comments?
1-800-645-2158
Principal Display Panel - 15 G Tube Carton
Rugby®
Maximum Strength
Lidocaine 4%
Pain and Itch Relief Cream
NDC 0536-1278-03
Compare to the active
ingredient in Gold Bond®
with 4% Lidocaine*
NET WT 0.52 OZ (15 g)
* Please review the disclaimer below.