Label: RADX- lidocaine lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-650-03 - Packager: Cosmetic Specialty Labs, Inc.
- 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 August 2, 2021
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- Active Incredients
- Purpose
- Uses
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive Ingredients
Water, Cetearyl Olivate, Sorbitan Olivate, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Cetyl Phosphate, Cetearyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Hippophae Rhamnoides (Sea Buckthorn) Extract, Hydrogenated Ethylhelxyl Olivate, Hydrogenated Olive Oil Unsaponifiables, Carica Papaya (Papaya) Seed Oil, Beta-Glucan, C12-C15 Alkyl Benzoate, Tocopheryl Linoleate/Oleate, Sodium Hyaluronate, Allentoin, Aloe Barbadensis, Bromelain, Xanthan Gum, Hydrolyzed Silk
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RADX
lidocaine lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-650 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED) XANTHAN GUM (UNII: TTV12P4NEE) ALOE VERA LEAF (UNII: ZY81Z83H0X) SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV) ALLANTOIN (UNII: 344S277G0Z) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PAPAYA (UNII: KU94FIY6JB) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SUNFLOWER OIL (UNII: 3W1JG795YI) ETHYLHEXYL OLEATE (UNII: R34927QY59) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL PHOSPHATE (UNII: VT07D6X67O) COCONUT OIL (UNII: Q9L0O73W7L) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP) FRUIT BROMELAIN (UNII: F0ZCA6O9QT) WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SORBITAN OLIVATE (UNII: MDL271E3GR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-650-03 100 mL in 1 TUBE; Type 0: Not a Combination Product 07/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/30/2021 Labeler - Cosmetic Specialty Labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty Labs, Inc. 032973000 manufacture(58133-650) , label(58133-650) , pack(58133-650)