Label: ZICAM COLD REMEDY- galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed gel
- NDC Code(s): 10237-472-20
- Packager: Church & Dwight Co., Inc.
- 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 February 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
- For nasal use only
Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and seek medical help right away.
When using this product
- avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.
- the use of individual swabs by more than one person may spread infection
- temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
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Directions
- for best results, use at the first sign of a cold and continue to use until symptoms completely subside
- adults and children 12 years of age and older:
- open tube (also see illustration on side of carton)
- hold tube between thumb and forefinger at the blue band
- with other hand, hold at handle base, snap open tube and pull out swab
- apply medication just inside first nostril. Using swirling motion, rotate swab 3 times within nostril. While swirling, gently press outside of first nostril to ensure transfer of medication. Re-dip swab in tube and mix to re-saturate with medication. Swirl 3 more times in the same nostril while gently pressing outside of nostril. Re-dip swab in tube and mix. Repeat identical sequence in second nostril. Do not insert swab more than 1/4" past nasal opening.
- discard swab after use
- wait at least 30 seconds before blowing nose
- use 1 tube every 3 hours, not to exceed 5 tubes in one 24 hour period
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions? Comments? Side Effects?
- PRINCIPAL DISPLAY PANEL - 20 Swab Tube Carton
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INGREDIENTS AND APPEARANCE
ZICAM COLD REMEDY
galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-472 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP 4 [hp_X] in 1.2 mL LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT 4 [hp_X] in 1.2 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 4 [hp_X] in 1.2 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) EUCALYPTOL (UNII: RV6J6604TK) EUGENOL (UNII: 3T8H1794QW) GLYCINE (UNII: TE7660XO1C) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUCCINIC ACID (UNII: AB6MNQ6J6L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-472-20 20 in 1 CARTON 02/28/2022 1 1.2 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/28/2022 Labeler - Church & Dwight Co., Inc. (001211952)
