Label: DCH PAIN RELIEF- lidocaine hcl 4% cream
- NDC Code(s): 72839-361-02
- 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 July 19, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
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WARNINGS
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.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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, Methylparaben, Steareth-21, Water.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DCH PAIN RELIEF
lidocaine hcl 4% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-361 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:72839-361-02 76.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/10/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/10/2021 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(72839-361)