DZUL - LIDO CREME- lidocaine hcl, menthol lotion

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]

ACTIVE INGREDIENT

Lidocaine HCl 4%

Menthol 1%

PURPOSE

Topical Analgesic

USES:

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

WARNINGS

For external use only.

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

WHEN USING

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.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

DZUL - LIDO CREME 
lidocaine hcl, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83037-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (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)
.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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83037-041-02	71 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	10/02/2023

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

Labeler - Caball Sales, Inc. (047422138)