DCH PAIN RELIEF ROLL-ON- lidocaine hcl 4% 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 Pain Relief Roll-On

Lidocaine HCl 4%

Topical Analgesic

For the temporary relief of pain and itching.

For external use only. Flammable--keep away from fire or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.

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.

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 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Acrylates/C10-30 Alkyl Acrylate 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, Methylparaben, SD Alcohol 40, Steareth-21, Water.

Carton

DCH PAIN RELIEF ROLL-ON 
lidocaine hcl 4% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-087
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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:72839-087-021 in 1 CARTON04/21/2022
171 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/21/2022
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-087)

Revised: 6/2023
Document Id: fda35d37-f36d-efc8-e053-6294a90a2bb8
Set id: fda35d37-f36e-efc8-e053-6294a90a2bb8
Version: 1
Effective Time: 20230608
 
Derma Care Research Labs, LLC