Label: COOL AND HEAT SORE MUSCLE ROLLER EVORA LABS- menthol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77375-008-02 - 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
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- 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 or use with a heating pad • avoid contact with
eyes and mucous membranes • do not apply to wounds or
damaged, broken or irritated skin • a transient burning sensation
may occur upon application but generally disappears in several
days • if severe burning sensation occurs, discontinue use
immediately • do not expose the area treated with product to heat
or direct sunlightStop use and ask doctor if • condition worsens • redness is
present • irritation develops • 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
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Directions
adults and children over 12 years: • apply generously to
affected area • massage into painful area until thoroughly
absorbed into skin • repeat as necessary, but no more than 3 to 4
times daily • IF MEDICINE COMES IN CONTACT WITH HANDS,
WASH WITH SOAP AND WATER
Children 12 years or younger: ask a doctor - Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOL AND HEAT SORE MUSCLE ROLLER EVORA LABS
menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77375-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 16 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CAPSAICIN (UNII: S07O44R1ZM) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77375-008-02 1 in 1 CARTON 12/21/2020 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 12/21/2020 Labeler - Evora Worldwide (081336028) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC 081030372 manufacture(77375-008)
