Label: MYDERM NUMBING ROLL-ON- inspec solutions llc cream
- NDC Code(s): 72667-058-01
- Packager: Inspec Solutions LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 2, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY
- INDICATIONS & USAGE
-
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 creamProduct 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) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 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 not final part348 01/02/2023 Labeler - Inspec Solutions LLC. (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC. 081030372 manufacture(72667-058)