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  5. Label Information: Lidocaine Anesthetic Cream

FDA Label for Lidocaine Anesthetic Cream

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 28 G TUBE BOX

Lidocaine Anesthetic Cream Product Label

The following document was submitted to the FDA by the labeler of this product Nationwide Pharmaceutical Llc. 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.

Other



Drug Facts


Active Ingredients



Lidocaine 4% w/w


Purpose



Local Anesthetic


Uses



For temporary relief of pain associated with minor cuts, minor burns, minor scrapes, sunburn, minor skin irritations, and insect bites.


Warnings



For external use only.


When Using This Product



  • do not get into eyes.
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not use in large quantities, particularly over raw or blistered areas.

Stop Use And Ask A Doctor If



  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase.

Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.


Directions



  • Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age. Consult a doctor.

Other Information



Store at USP controlled room temperature 20-25 °C (68-77 °F).


Inactive Ingredients



Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.


Questions?



1-800-697-3329


Principal Display Panel - 28 G Tube Box



Nationwide
Pharmaceutical

NDC 69375-0005-30

4% Lidocaine
Topical Anesthetic Cream

NET WT 1 oz ( 28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Box - lidocaine 01

PRINCIPAL DISPLAY PANEL - 28 g Tube Box - lidocaine 01


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