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

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83037-041-02

Lidocaine HCl 4%

Menthol 1%

Topical Analgesic

USES:

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

For external use only.

Ask a doctor before use if you have redness over affected area.

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.

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.

Ask a health professional before use.

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

DIRECTIONS:

Adults and children over 12 years of age

Apply a small amount to 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.

Children under 12 years of age; do not use unless directed by doctor.

Store at room temperature 15° - 30°C (59° - 86°F)

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 ROLL-ON

LIDO CREME

DZUL - LIDO CREME 
lidocaine hcl, menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83037-041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL (UNII: 66YXD4DKO9)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
.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)  
CHAMOMILE (UNII: FGL3685T2X)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83037-041-0271 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/17/2022
Labeler - Caball Sales, Inc. (047422138)

Revised: 9/2023
Document Id: 0634096d-328c-db03-e063-6394a90a63cd
Set id: 063387e4-a1b1-a467-e063-6294a90a6cbd
Version: 1
Effective Time: 20230925
 
Caball Sales, Inc.