Label: HOO GARGLE APPLE SPEARMINT FLAVOR- sodium fluoride liquid
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NDC Code(s):
83367-100-01,
83367-100-02,
83367-100-03,
83367-100-04, view more83367-100-05, 83367-100-06, 83367-100-07, 83367-100-08
- Packager: Nuriearth Global Co., Ltd.
- 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 April 13, 2023
If you are a consumer or patient please visit this version.
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- Hoo Gargle Apple Spearmint Flavor Active Ingredient
- Hoo Gargle Apple Spearmint Flavor Ask Doctor
- Hoo Gargle Apple Spearmint Flavor Warning
- Hoo Gargle Apple Spearmint Flavor Keep Out of Reach of Children
- Hoo Gargle Apple Spearmint Flavor Questions
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Hoo Gargle Apple Spearmint Flavor Directions
Directions
adults and children 6 years of age and older:
use before or after brushing your teeth with a toothpaste or use whenever you want but do not use more than 3 times a day
vigorously swish 10mililiters (2 teaspoonfuls) of rinse between your teeth for 1 minutes 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 supervision - Hoo Gargle Apple Spearmint Flavor Inactive Ingredient
- Hoo Gargle Apple Spearmint Flavor Indications
- Hoo Gargle Apple Spearmint Flavor Purpose
- Hoo Gargle Apple Spearmint Flavor Package Label
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INGREDIENTS AND APPEARANCE
HOO GARGLE APPLE SPEARMINT FLAVOR
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83367-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) 10 mg in 1 mL ALANINE (UNII: OF5P57N2ZX) 0.5 mg in 1 mL (2-AMINO-5,6-DICHLOROQUINAZOLIN-3(4H )-YL)ACETIC ACID (UNII: 03TUA9L576) 0.5 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) 0.6 mg in 1 mL SODIUM ACETATE (UNII: 4550K0SC9B) 0.5 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83367-100-02 1 in 1 PACKAGE 04/01/2023 1 NDC:83367-100-01 15 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:83367-100-04 1 in 1 PACKAGE 04/01/2023 2 NDC:83367-100-03 30 mL in 1 PACKET; Type 0: Not a Combination Product 3 NDC:83367-100-06 1 in 1 PACKAGE 04/01/2023 3 NDC:83367-100-05 50 mL in 1 PACKET; Type 0: Not a Combination Product 4 NDC:83367-100-08 1 in 1 PACKAGE 04/01/2023 4 NDC:83367-100-07 100 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M022 04/01/2023 Labeler - Nuriearth Global Co., Ltd. (695456265) Registrant - Nuriearth Global Co., Ltd. (695456265) Establishment Name Address ID/FEI Business Operations Miko Co Ltd 695188803 manufacture(83367-100)
