Label: MYHEALTH MOOD CARE SPORT WOMEN- aluminum sesquichlorohydrate aerosol, spray
- NDC Code(s): 80661-014-01
- Packager: Aeroflex Industria de Aerosol Ltda
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 27, 2022
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- Active Ingredients
- Purpose
- Uses
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Warnings
- FLAMMABLE. DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING. CAN CAUSE SERIOUS INJURY OR DEATH.
- Keep away from face and mouth to avoid breathing in.
- Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F/50°C or in enclosed places that could overheat.
- Do not use on broken skin. Stop use if rash or irritation occurs.
- Ask a doctor before using if you have kidney disease.
- KEEP OUT OF REACH OF CHILDREN.
- USE ONLY AS DIRECTED. INTENTIONAL MISUSE BY DELIBERATELY CONCENTRATING AND INHALING THE CONTENTS CAN BE HARMFUL OR FATAL.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive Ingredients
- Product label
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INGREDIENTS AND APPEARANCE
MYHEALTH MOOD CARE SPORT WOMEN
aluminum sesquichlorohydrate aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80661-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 25 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTANE (UNII: 6LV4FOR43R) ISOBUTANE (UNII: BXR49TP611) PROPANE (UNII: T75W9911L6) METHYLAL (UNII: 7H1M4G2NUE) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) QUATERNIUM-18 (UNII: O7757NO1VL) HECTORITE (UNII: 08X4KI73EZ) PROPYLENE CARBONATE (UNII: 8D08K3S51E) 2-METHYL 5-CYCLOHEXYLPENTANOL (UNII: 460837ILID) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80661-014-01 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2023 Labeler - Aeroflex Industria de Aerosol Ltda (898397347) Establishment Name Address ID/FEI Business Operations Aeroflex Industria de Aerosol Ltda 898397347 manufacture(80661-014)