Label: FLUNADA COLD AND FLU RELIEF- eucalyptol, eucalyptus globulus whole, menthol, sambucus nigra whole, methyl salicylate spray, metered
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Contains inactivated NDC Code(s)
NDC Code(s): 54705-160-01, 54705-160-20 - Packager: Flutrends International Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 16, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients: (in each 20 mL)
- Purpose
- DESCRIPTION
- Uses:
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Warnings:
- Do not use if pump bottle seal is broken.
- Use of this dispenser by more than one person can spread infection.
- Ask a doctor before use if you have asthma or known allergies to any product ingredient, or a history of nose bleeds.
- Consult a healthcare professional if you are pregnant or breast-feeding.
- Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
- Ask a doctor before use in children younger than 4 years of age.
- Keep out of reach of children.
- Directions:
- Inactive Ingredients:
- FOR QUESTIONS / COMMENTS:
- KEEP OUT OF REACH OF CHILDREN
- Image of 20mL Carton and Label
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INGREDIENTS AND APPEARANCE
FLUNADA COLD AND FLU RELIEF
eucalyptol, eucalyptus globulus whole, menthol, sambucus nigra whole, methyl salicylate spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54705-160 Route of Administration NASAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 3 [hp_X] in 20 mL EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3) (EUCALYPTUS GLOBULUS WHOLE - UNII:SI1P2XF3M3) EUCALYPTUS GLOBULUS WHOLE 3 [hp_X] in 20 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 [hp_X] in 20 mL SAMBUCUS NIGRA WHOLE (UNII: 4X6JT95SYN) (SAMBUCUS NIGRA WHOLE - UNII:4X6JT95SYN) SAMBUCUS NIGRA WHOLE 2 [hp_X] in 20 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 3 [hp_X] in 20 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) XYLITOL (UNII: VCQ006KQ1E) POLOXAMER 407 (UNII: TUF2IVW3M2) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) THYMOL (UNII: 3J50XA376E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54705-160-01 1 in 1 CARTON 07/08/2014 12/31/2017 1 NDC:54705-160-20 20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/18/2012 Labeler - Flutrends International Corporation (054162682) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 manufacture(54705-160)