Active Ingredients
Arnica Montana 1X - 7% HPUS
Laboflex Arnipatch Muscle And Joint Patch
FDA Label NDC 83655-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboflex, Inc. for the product Laboflex Arnipatch Muscle And Joint Patch (NDC 83655-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, keep out of reach of children, stop and ask doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Muscle strain, Bruising
Uses
- * For the temporary relief of muscle pain and stiffness due to minor injuries, overexertion and
falls. Reduces pain, swelling and discoloration from bruises.
Warnings
For external use only.
Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients. Do not use if you are allergic to the dressing or any of its components.
When Using This Product
When using this product ■ Use only as directed ■ Do not bandage tightly ■ Avoid contact with eyes ■ Do not apply to open wounds or damaged skin
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.
Stop And Ask Doctor If
Stop and ask doctor if ■Condition worsens ■ Irritation occurs ■ Symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breastfeeding
If pregnant or breastfeeding, ask a health professional before use.
Directions
Adults and children 12 years of age and over
■ Clean and dry affected area ■ Remove patch from film ■ Place healing patch on intact skin ■ Patch may be worn up to 12 hours.
Children under 12 years of age Consult a doctor
Inactive Ingredients
Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Sodium, Glycerin, Methyl- paraben, Mint Oil, Partially Neutralized Polyacrylic Acid, Polysorbate 80, Povidone-K90, Propylparaben, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Purified Water
Questions Of Comments?
Call toll-free 1-800-655-0252 or email: [email protected]
Product Packaging
Carton (Arnicapatchbox)
Label (Arnicapatch)
* Please review the disclaimer below.
