Label: GOGLAMA NAF RNS MINT- sodium fluoirde rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 62007-700-16 - Packager: Ross Healthcare Inc.
- 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 November 23, 2017
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DOSAGE & ADMINISTRATION
Adults and children 6 years of age and older:
use once a day after brushing your teeth with a toothpaste
remove cap
hold bottle upright and squeeze. Fill to FILL LINE
pour out. Only the correct 10 milliliters dose will pour out
vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervisionchildren under 6 years of age: consult a dentist or doctor.
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOGLAMA NAF RNS MINT
sodium fluoirde rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62007-700 Route of Administration TOPICAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.04 mg in 1 mL XYLITOL (UNII: VCQ006KQ1E) 0.5 mg in 1 mL SUCRALOSE (UNII: 96K6UQ3ZD4) 0.01 mg in 1 mL Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62007-700-16 1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/22/2017 Labeler - Ross Healthcare Inc. (244249012)