Label: DCH NERVE PAIN RELIEF ROLL-ON- lidocaine hcl 4%, menthol 1% gel
- NDC Code(s): 72839-014-03
- Packager: Derma Care Research Labs, 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 June 28, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
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WARNINGS
For external use only. Flammable--keep away from fire or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop use and ask a doctor if the condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Adults and children 12 years and older: apply to the affected area, not more than 6 to 8 hours. Do not exceed 3 applications in a 24-hour period. Massage into painful area until thoroughly absorbed into the skin. AFTER APPLYING WASH HANDS WITH SOAP ANDWATER. Children under 12 years of age: ask a doctor.
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INACTIVE INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., 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, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Methylparaben, Polysorbate 60, Steareth-21, Water.
- PREGNANCY OR BREAST FEEDING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DCH NERVE PAIN RELIEF ROLL-ON
lidocaine hcl 4%, menthol 1% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-014 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 HYDROCHLORIDE ANHYDROUS 4 g in 100 g Inactive Ingredients Ingredient Name Strength ISOHEXADECANE (UNII: 918X1OUF1E) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) STEARETH-21 (UNII: 53J3F32P58) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETETH-20 PHOSPHATE (UNII: 921FTA1500) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) METHYLPARABEN (UNII: A2I8C7HI9T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R) DIMETHICONE 200 (UNII: RGS4T2AS00) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72839-014-03 85 g in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/30/2023 Labeler - Derma Care Research Labs, LLC (116817470) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(72839-014)
