Zionodil External (Page 2 of 2)

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

PEDIATRIC USE

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

Adverse Reactions to Zionodil External

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

DOSAGE AND ADMINISTRATION

Apply a thin film to the affected area 1 -3 times daily or as directed by a physician.

HOW SUPPLIED

Lidocaine HCl 3% Lotion is supplied in the following size:

SIZE NDC#
6oz. (177 mL) Bottle 73247-391-06

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

STORAGE

Store at 25°C (77°F); excursions permitted to 15° — 30°C (59° — 86°F). Protect from freezing [See USP Controlled Room Temperature].

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

Mfg. for & Distributed by: Bodysphere, LLC, Las Vegas, NV 89120

For Customer Service or Adverse Reactions: 1-866-660-2626

PRINCIPAL DISPLAY PANEL — 177 ml Bottle Label

NDC 73247-0391-06
Rx Only

Zionodil
Lidocaine HCL 3%
External Lotion

Topical Anesthetic

Smooth
Easily Spreadable

Net Wt. 6 oz (177 ml)

BODYSPHERE +
MADE IN USA

PRINCIPAL DISPLAY PANEL -- 177 ml Bottle Label
(click image for full-size original)
ZIONODIL EXTERNAL
lidocaine hydrochloride lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73247-391
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 30 mg in 177 mL
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73247-391-06 177 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/20/2019
Labeler — Bodyshphere, LLC (117131105)

Revised: 11/2019 Bodyshphere, LLC

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