Label: PAIN RELIEF ROLL ON EVORA LABS- lidocaine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77375-007-02 - Packager: Evora Worldwide
- 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 January 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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Warnings
For externa use only.
When using this product • use only as directed • do not bandage tightly • avoid contact with
eyes • do not apply to wounds or damaged skin • do not use in large quantities, particularly over raw surface or blistered areas.Stop use and ask doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days
Flammable • keep away from fire or flame
If pregnant or breast-feeding, ask a health professional before
use. - Keep out of reach of children
- Directions
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF ROLL ON EVORA LABS
lidocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77375-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) MYRISTYL TRISILOXANE (UNII: J7960S4R1T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 PHOSPHATE (UNII: 921FTA1500) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) ALCOHOL (UNII: 3K9958V90M) STEARETH-21 (UNII: 53J3F32P58) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77375-007-02 1 in 1 CARTON 12/22/2020 1 74 mL in 1 BOTTLE, PLASTIC; 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 12/22/2020 Labeler - Evora Worldwide (081336028) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC 081030372 manufacture(77375-007)
