Label: PAIN RELIEF ROLLER SIGNATURE CARE- menthol 4% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 21130-764-03 - Packager: Better Living
- 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 18, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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WARNINGS
Warnings
For external use only.Flammable: Do not use while smoking or near heat or flame
When using this product • avoid contact with eyes or mucouse membranes•do not apply to wounds or damaged skin • do not apply to the irritated skin • do not bandage • wash hands after use with cool water • do not use with heating pad or device.Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within
a few days. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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Inactive ingredients
Aloe Barbadensis Leaf Extract
Arctium Lappa Root (Burdock) Extract
Arnica Montana Flower Extract
Boswellia Carterii Resin Extract
Calendula Officinalis Extract
Camellia Sinensis Leaf Extract
Camphor
Carbomer
FD&C Blue #1
FD&C Yellow #5
Glycerin
Ilex Paraguariensis (Mate) Leaf Extract
Isopropyl Alcohol
Isopropyl Myristate
Melissa Officinalis (Lemon Balm) Leaf Extract
Silica
Tocopheryl Acetate
Triethanolamine
Water - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF ROLLER SIGNATURE CARE
menthol 4% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-764 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) Glycerin (UNII: PDC6A3C0OX) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) Isopropyl Alcohol (UNII: ND2M416302) Isopropyl Myristate (UNII: 0RE8K4LNJS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-764-03 73 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 03/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/30/2018 Labeler - Better Living (009137209) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(21130-764) , label(21130-764)
