Label: EEZ-AWAY RELIEF- menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 69678-101-04, 69678-101-06, 69678-101-08 - Packager: EEZAWAY RELIEF INC
- 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 June 6, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT:
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRECAUTIONS
- WARNINGS
- DIRECTIONS FOR USE
- INACTIVE INGREDIENT
- QUESTIONS
- Packaging
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INGREDIENTS AND APPEARANCE
EEZ-AWAY RELIEF
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69678-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) IODINE (UNII: 9679TC07X4) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYOXYL-10 OLEYL ETHER (UNII: JD797EF70J) PEG-75 LANOLIN (UNII: 09179OX7TB) PPG-20 METHYL GLUCOSE ETHER DISTEARATE (UNII: 0057334FAB) SODIUM IODIDE (UNII: F5WR8N145C) SODIUM THIOSULFATE (UNII: HX1032V43M) Product Characteristics Color brown (amber) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69678-101-08 236.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/19/2015 2 NDC:69678-101-06 177.4 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/31/2017 3 NDC:69678-101-04 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/19/2015 Labeler - EEZAWAY RELIEF INC (079751465) Establishment Name Address ID/FEI Business Operations Topiderm Inc. 049121643 manufacture(69678-101)