Label: EOS THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP- menthol, camphor, allantoin ointment
- NDC Code(s): 70170-0017-1
- Packager: eos Products LLC
- 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 May 22, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive Ingredients:
Bis-Diglyceryl Polyacyladipate-2, Jojoba Esters, Hydrogenated Polyisobutene, Ricinus Communis (Castor) Seed Oil, Dimer Dilinoleyl Dimer Dilinoleate, Diiosteryl Malate, Octyldodecanol, Nylon-12, Beeswax/Cera Alba (Cire d'abeille), Helianthus Annuus (Sunflower) Seed Wax, Flavor (Armoa), Silica Dimethyl Silylate, Butyrospermum Parkii (Shea) Butter, Theoborma Cacao (Cocoa) Seed Butter, Mentha Piperita (Peppermint) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Acacia Decurrens Flower Wax, Stearalkonium Hectorite, Polyglycerin-3, Propylene Carbonate, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Citric Acid, Limonene1. 1Component of Flavor.
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- Principal Display Pantel - 0.35 fl. oz. (10 mL)
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INGREDIENTS AND APPEARANCE
EOS THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP
menthol, camphor, allantoin ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70170-0017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.0594 g in 10 mL CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 0.0475 g in 10 mL ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.0475 g in 10 mL Inactive Ingredients Ingredient Name Strength HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) YELLOW WAX (UNII: 2ZA36H0S2V) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) PROPYLENE CARBONATE (UNII: 8D08K3S51E) COCOA BUTTER (UNII: 512OYT1CRR) SHEA BUTTER (UNII: K49155WL9Y) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) DIMER DILINOLEYL DIMER DILINOLEATE (UNII: 0E2D5DBT7M) NYLON-12 (UNII: 446U8J075B) SUNFLOWER OIL (UNII: 3W1JG795YI) MENTHA PIPERITA LEAF (UNII: A389O33LX6) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LIMONENE, (+)- (UNII: GFD7C86Q1W) TOCOPHEROL (UNII: R0ZB2556P8) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) Product Characteristics Color white Score Shape TRIANGLE Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70170-0017-1 1 in 1 BLISTER PACK 07/01/2020 1 10 mL in 1 TUBE; 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 07/01/2020 Labeler - eos Products LLC (803969620) Establishment Name Address ID/FEI Business Operations Raining Rose, Inc. 083819404 manufacture(70170-0017)
