Rr Roll-on For Pain
FDA Label NDC 83048-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Revolutionary Relief Dba Medical Xlabs for the product Rr Roll-on For Pain (NDC 83048-001). 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 ingredient, purpose, uses, warnings, direaction, additional information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Analgesic

Uses

Temporarily relieves pain and itching

Warnings

  • For external use only  Use only as direacted
  • Do not allow contact with the eyes and mucuous membrances.
  • Do not apply to wounds or damaged skin
  • Do not use at the same time as other topical analgesics 
  • Stop use and ask a doctor if : allergic reaction occurs 
  • condition worsen or does not improve within 7 days 
  • redness, irritation, swelling, pain or other symptoms begin or increase.
  • If pregnant or Breastfeeding 

    •    Ask a health professional before use.

    Keep out of reach of children 

      If swallowed, get medical help or Contact a Posion Control right away. Emergency number : 1-800-222-1222

Direaction

    Adults and children 12 years of age or older:

  • Apply to affected area not more than 3 to 4 times daily
  • Children under two years of age, consult a physicion

Additional Information

Store in a cool, dry place

Inactive Ingredients

Aqua, Alcohol Denat., Butylene Glycol, Steareth-21, Steareth-2, Cetyl Alcohol, Hemp Seed Oil, Glycerin, Caprylyl Glycol, Kannopia-Active TM Proprietary Hemp Extract, Tocopherol, Arnica Montana Flower Extract, Boswellia Serrata (Frankincense) Extract, Plantago Major (Plantain) Leaf
Extract, Phenoxyethanol, Hexelene Glycol, Xanthan Gum, Hexyl Cinnamic Aldehyde, Coumarin, Limonene, Peppermint

Product Label

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