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Renovo Lido5 Cream

Generic Name: lidocaine, menthol and capsaicin
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION

Disclaimer: The FDA has not evaluated this drug, and FDA has not approved this labeling.

Renovo Lido5 is a Lidocaine 5%, Menthol 3% and Capsaicin 0.05% cream which is a topical anesthetic and analgesic indicated for the relief of pain related to minor cuts, grazes and irritation

INDICATIONS AND USAGE

Renovo Lido5 is a topical anesthetic and analgesic indicated for the relief of pain related to minor cuts, grazes and irritations.

CONTRAINDICATIONS

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

WARNINGS

For external use only.
Use only as directed.
Avoid contact with eyes and mucous membranes.
Do not cover with bandage.
Do not use on wounds or damaged skin.
Consult physician for children under 12.
Do not use if you are allergic to Menthol, Capsaicin or Lidocaine
Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs.


KEEP OUT OF REACH OF CHILDREN.

Precautions

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Renovo Lido5 Cream should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.

USE IN PREGNANCY:

Teratogenic Effects; Pregnancy Category B.

Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

NURSING MOTHERS:

Lidocaine is excreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when lidocaine is administered to a nursing woman.

PEDIATRIC USE:

Dosage in pediatric patients should be reduced commensurate with age, body weight, and physical condition.

ADVERSE REACTIONS:

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

CALL YOUR DOCTOR ABOUT SIDE EFFECTS.

DOSAGE AND ADMINISTRATION

Instructions for Use

Clean and dry affected area
Apply directly to area of pain
Apply to affected area not more than 4 times daily
Wash hands with soap after applying.

Adults and children 12 years and over

apply to affected area not more than 4 times daily

Children under 12 years

consult physician before use

Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088 1-800-FDA-1088 FREE.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence.

Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86º F). See USP Controlled Room Temperature. Protect from freezing.

HOW SUPPLIED

Renovo Lido5is supplied in a single box with a 30 or 60 gram tube inside the box.

Renovo Lido5 Cream 60 gram tube NDC 69176-050-60

Renovo Lido5 Cream 30 gram tube NDC 69176-050-30

Storage: Store below 25°C. Avoid direct sunlight.

Distributed by:
TMIG, Inc., Marietta, GA 30062
770-579-8883

Manufactured exclusively for TMIG Inc, by:
Pocono Coated Products, LLC
Greensboro, N.C. USA 27407

Distilled Water, Avocado Oil, Apricot Kernel Oil, Olive Oil, Cocoa Butter, Polysorbate 80, Glycerin, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Titanium Dioxide, Propylene Glycol, Petrolatum, FD&C Blue 1 and FD&C Red 40

Renovo Lido5

Lido 5

RENOVO LIDO5 
lidocaine menthol and capsaicin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69176-050
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 1.8 g  in 60 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 3 g  in 60 g
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.03 g  in 60 g
Inactive Ingredients
Ingredient Name Strength
AVOCADO OIL  
APRICOT KERNEL OIL  
OLIVE OIL  
COCOA BUTTER  
PHENOXYETHANOL  
ETHYLPARABEN  
PROPYLPARABEN  
TITANIUM DIOXIDE  
PROPYLENE GLYCOL  
PETROLATUM  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
BUTYLPARABEN  
GLYCERIN  
METHYLPARABEN  
POLYSORBATE 80  
WATER  
Packaging
# Item Code Package Description
1 NDC:69176-050-60 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2015
Labeler - TMIG, Inc. (036572986)
Registrant - TMIG, Inc. (036572986)
Revised: 06/2015
 
TMIG, Inc.



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