Label: DRAGON PAIN NUMBING ROLL-ON- lidocaine hydrochloride liquid
- NDC Code(s): 50066-411-02
- Packager: Genomma Lab USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 26, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
Do not use
- on large areas of the body, particularly over raw surfaces or blistered areas
- on wounds or damaged skin
When using this product
- use only as directed
- avoid contact with eyes
- do not apply tight bandages
- do not apply a heating pad to treated skin
- do not use in large quantities
- Directions
- Other information
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Inactive ingredients
Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Decolorized Aloe Barbadensis Leaf Juice, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl StearateSE, Phenoxyethanol, Steareth-21, Water
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 71 g Container Carton
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INGREDIENTS AND APPEARANCE
DRAGON PAIN NUMBING ROLL-ON
lidocaine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-411 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine hydrochloride (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1 g Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ceteth-20 phosphate (UNII: 921FTA1500) Steareth-21 (UNII: 53J3F32P58) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-411-02 1 in 1 CARTON 07/24/2021 1 71 g in 1 CONTAINER; 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 07/24/2021 Labeler - Genomma Lab USA (832323534)