DCH PAIN RELIEF- lidocaine hcl 4% cream 
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 Cream, Lidocaine HCl 4%

Lidocaine HCl 4%

Topical Analgesic

Temporarily relieves minor pain.

For external use only.

Do not use on large areas of the body or on cut, irritated, or swollen skin, on puncture wounds, for more than one week without consulting a doctor.

When using this product use only as directed. Read and follow directions on this carton, avoid contact with eyes and mucous membranes, do not apply to wounds or damaged, broken, or irritated skin, do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use, do not use at the same time as other topical analgesics, a transient burning sensation may occur upon application but generally disappears in several days, avoid applying into skin folds.

Stop use and ask a doctor if the condition worsens, redness is present, irritation develops, 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 over 12 years: apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period. AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children under 12 years or younger: 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, Methylparaben, Steareth-21, Water.

Carton

DCH PAIN RELIEF 
lidocaine hcl 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-361
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:72839-361-0276.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/10/2021
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-361)

Revised: 7/2023
Document Id: 00dd70f3-ecc2-33ba-e063-6294a90a4f32
Set id: 00dd70f3-ecc3-33ba-e063-6294a90a4f32
Version: 1
Effective Time: 20230719
 
Derma Care Research Labs, LLC