DZUL - LIDO CREME by Caball Sales, Inc. 83037-423-02

DZUL - LIDO CREME by

Drug Labeling and Warnings

DZUL - LIDO CREME by is a Otc medication manufactured, distributed, or labeled by Caball Sales, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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83037-423-02

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.3 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCOL STEARATE (UNII: 0324G66D0E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE 1000 (UNII: MCU2324216)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
ROSEMARY OIL (UNII: 8LGU7VM393)
MINERAL OIL (UNII: T5L8T28FGP)
SALIX ALBA BARK (UNII: 205MXS71H7)
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83037-423-02	71 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	10/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/17/2022	04/28/2025

Labeler - Caball Sales, Inc. (047422138)

Revised: 10/2023

Document Id: 06bfe007-b26c-085c-e063-6394a90a3e39

34390-5

Set id: eb3e4c75-fb7f-5c13-e053-2995a90a4767

Version: 2

Effective Time: 20231002