DCH NERVE PAIN RELIEF ROLL-ON- lidocaine hcl 4%, menthol 1% gel 
Derma Care Research Labs, LLC

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.

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DCH Nerve Pain Relief Roll-On

Lidocaine HCl 4%, Menthol 1%

Topical Analgesic

Temporarily relieves minor pain.

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.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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.

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.

If pregnant or breastfeeding, ask a health professional before use.

Label

DCH NERVE PAIN RELIEF ROLL-ON 
lidocaine hcl 4%, menthol 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-014-0385 g in 1 BOTTLE; Type 0: Not a Combination Product05/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/30/2023
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-014)

Revised: 6/2023
Document Id: ff32cbb2-79ea-9158-e053-6394a90ac357
Set id: ff32cbb2-79eb-9158-e053-6394a90ac357
Version: 1
Effective Time: 20230628
 
Derma Care Research Labs, LLC