DZUL – LIDO CREME MAXIMUM STRENGTH: Package Insert and Label Information

DZUL — LIDO CREME MAXIMUM STRENGTH- menthol and lidocaine lotion
Caball Sales, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Lidocaine ……………… 4%

Menthol ………………. 2.3%

Topical Analgesic

USES:

For temporary local relief of minor pain in muscles or joints.

For external use only.

Use only as directed.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly or use with a heating pad.
A transient burning sensation or redness may occur upon application but generally disappears in several days.

Do not apply on large areas of the body or on damaged, broken, or irritated skin.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask a health professional before use.

STOP USE AND ASK A DOCTOR IF:

Redness is present.
Condition worsens.
Irritation develops.
Symptoms persist for more than 7 days or clear up and occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

DIRECTIONS:

Apply a small amount on the affected area.
Massage in a circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.

Store tightly closed in a dry place at room temperature.

Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glycol Stearate, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Dimethicone, Glycerin, Caprylhydroxamic Acid, Caprylyl Glycol, Eucalyptus Globulus Leaf Oil, Phenoxyethanol, Methylpropanediol, Acrylamide/Sodium Acrylate Copolymer, Paraffinum Liquidum, Trideceth-6, Methylsulfonylmethane, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosmarinus Officinalis (Rosemary) Oil, Tocopheryl Acetate, Arnica Montana Flower Extract, Salix Alba Bark Extract, Glucosamine Sulfate, Chamomilla Recutita (Matricaria) Flower Extract, Capsicum Annuum Fruit Extract.

DZUL — LIDO CREME MAXIMUM STRENGTH lidocaine, menthol lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83037-423 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 2.3 g in 100 g LIDOCAINE (LIDOCAINE) LIDOCAINE 4 g in 100 g

Inactive Ingredients Ingredient Name Strength ALMOND OIL DIMETHYL SULFONE METHYLPROPANEDIOL ARNICA MONTANA FLOWER TRIDECETH-6 .ALPHA.-TOCOPHEROL ACETATE WATER ISOPROPYL MYRISTATE PEG-100 STEARATE STEARYL ALCOHOL GLYCOL STEARATE SODIUM LAURYL SULFATE GLYCERIN DIMETHICONE 1000 CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL PHENOXYETHANOL ALOE VERA LEAF GLYCERYL STEARATE SE EUCALYPTUS GLOBULUS LEAF ROSEMARY OIL MINERAL OIL CAPSICUM ANNUUM WHOLE SALIX ALBA BARK

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:83037-423-02 71 g in 1 BOTTLE, WITH APPLICATOR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/17/2022

Labeler — Caball Sales, Inc. (047422138)

Revised: 10/2022 Caball Sales, Inc.