MYDERM MEDICAL 5 LIDOCAINE NUMBING ROLL-ON- lidocaine stick

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine 5%

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

WHEN USING

When using this product avoid conatct with the eyes or muccous membranes.

PURPOSE

Lidocaine 5% ------------------------------------------------------------Local Anesthetic

WARNINGS

For external use only.

STOP USE

Stop use and ask doctor if condition worsens, or symtoms persist for more than 7 days,or clear up and reoccur again within a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Aloe Vera Barbadensis Leaft Juice

Inactive ingredients

2-animo-2methyl-1propanol

2-Methylamino-2-methyl-1-propanol

Cetearyl Alcohol

Citric Acid

Dimethicone

Disodium EDTA

Ethanol

Ethyhexylglycerin

Glyceril Stearate

Phenoxyethanol

Potassium Sorbate

Silicone Gel

Sodium Benzoate

Steareth-21

Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYDERM MEDICAL 5 LIDOCAINE NUMBING ROLL-ON 
lidocaine stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-285
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DIMETHICONE 100 (UNII: RO266O364U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-21 (UNII: 53J3F32P58)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-285-01	89 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/06/2024

Labeler - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(72667-285)