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
(click image for full-size original)

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.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.