![ZICAM COLD REMEDY (GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT, AND SCHOENOCAULON OFFICINALE SEED) GEL [MATRIXX INITIATIVES, INC.]](https://medic.hrt.org//dailymed/images/797480af-67a3-4700-adef-fa447ababaab/zicam-01.jpg)
| NDC | 62750-073-10 |
| Set ID | 797480af-67a3-4700-adef-fa447ababaab |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Matrixx Initiatives, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- 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 no use
- Other information
- Inactive ingredients
- Questions? Comments? Side Effects?
- SPL UNCLASSIFIED SECTION
- 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:62750-073 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:62750-073-10 20 in 1 CARTON 02/28/2015 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 02/28/2015 Labeler - Matrixx Initiatives, Inc. (790037253) Establishment Name Address ID/FEI Business Operations Unicep 790263909 MANUFACTURE(62750-073)
