Label: DCH PAIN RELIEF ROLL-ON- lidocaine hcl 4% gel
- NDC Code(s): 72839-087-02
- Packager: Derma Care Research Labs, LLC
- Category: HUMAN OTC DRUG LABEL
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 8, 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. 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.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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INACTIVE INGREDIENT
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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DCH PAIN RELIEF ROLL-ON
lidocaine hcl 4% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-087 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g Inactive Ingredients Ingredient Name Strength 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:72839-087-02 1 in 1 CARTON 04/21/2022 1 71 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/21/2022 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(72839-087)