MYDERM NUMBING ROLL-ON- inspec solutions llc cream

myDerm Numbing Roll-On by

Drug Labeling and Warnings

myDerm Numbing Roll-On by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine HCI 5%

PURPOSE

Uses Helps relieve anorectal symptoms (pain, soreness, burning, itching). Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

WARNINGS

Warnings For external use only

WHEN USING

When using this product avoid contact with the eyes or mucous membranes.

STOP USE

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or dear up and reoccur again within a few days. Do not use if pregnant or breast-feeding.

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY

Do not use if pregnant or breast-feeding.

INDICATIONS & USAGE

Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2

INACTIVE INGREDIENT

Inactive Ingredients Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol,

C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl

Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl

Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl

Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21 , Water.

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYDERM NUMBING ROLL-ON 
inspec solutions llc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
STEARETH-21 (UNII: 53J3F32P58)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-058-01	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/02/2023

Labeler - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-058)