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  5. Label Information: Dologesic Roll-on

FDA Label for Dologesic Roll-on

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. OTC - QUESTIONS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dologesic Roll-on Product Label

The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division, Inc.. 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.

Otc - Active Ingredient



Active Ingredient

Lidocaine HCL, USP 4% 


Otc - Purpose



Purpose

Topical Anesthetic


Indications & Usage



Use

Temporarily relieves minor pains


Warnings



Warnings

For external use only

Do not use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

    • When using this product

    • use only as directed. Read and follow all directions and warnings on this label.
    • do not allow contact with eyes
    • do not bandage or apply local heat (such as heating pads) to the area of use.

      • Stop use and ask doctor if

      • condition worsens
      • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a doctor 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.


Dosage & Administration



Directions

  • Adults and children over 12 years of age
  • Apply generously to the affected area as needed every 6-8 hours, not to exceed 3 application in a 24 hour period.
  • Not for use in children under 12 years of age.

Inactive Ingredient



Inactive ingredients

camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham gum.


Otc - Questions



Questions

Llorens Pharmaceutical International Division, Inc.

Miami Fl 33147


Package Label.Principal Display Panel



DologesicRollOn - dologesicrollon

DologesicRollOn - dologesicrollon


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