Label: MIRAKEL PAIN RELIEF ROLL-ON- lidocaine hcl gel
- NDC Code(s): 78589-257-03
- Packager: Sanvio, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 30, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only.
Flammable--keep away from fire or flame.
Do not use
- if you have an allergic reaction to lidocaine or other local anesthetics
- on large areas of the body or on cut, irritated, blistered, or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
Stop use and ask a doctor if
- condition worsens
- severe burning sensation, redness, rash, or irritation develops
- symptoms persist for more than 7 days or clear p and occur again within a few days
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Water, Alcohol Denat., Glyceryl Stearate, Cetearyl Alcohol, Dimethicone, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Salix Alba (Willow) Bark Extract, Curcuma Longa (Turmeric) Root Extract, Mentha Piperita (Peppermint) Leaf Extract, Eucalyptus Globulus Leaf Oil, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Ceteth-20 Phosphate, Dicetyl Phosphate, Disodium EDTA, Ethylhexylglycerin, Steareth-21, Methylparaben
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIRAKEL PAIN RELIEF ROLL-ON
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78589-257 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 C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) METHYLPARABEN (UNII: A2I8C7HI9T) MENTHA PIPERITA LEAF (UNII: A389O33LX6) ALCOHOL (UNII: 3K9958V90M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) EUCALYPTUS OIL (UNII: 2R04ONI662) ALOE VERA LEAF (UNII: ZY81Z83H0X) STEARETH-21 (UNII: 53J3F32P58) GLYCERIN (UNII: PDC6A3C0OX) ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V) CETETH-20 PHOSPHATE (UNII: 921FTA1500) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE 200 (UNII: RGS4T2AS00) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) SALIX ALBA BARK (UNII: 205MXS71H7) TURMERIC (UNII: 856YO1Z64F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78589-257-03 85 g in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 03/01/2023 Labeler - Sanvio, Inc. (100812165) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(78589-257)
