Label: HOO GARGLE ROOIBOS TEA FLAVOR- sodium fluoride liquid
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NDC Code(s):
83367-102-01,
83367-102-02,
83367-102-03,
83367-102-04, view more83367-102-05, 83367-102-06, 83367-102-07, 83367-102-08
- 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 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Hoo Gargle Rooibos Tea Flavor Active Ingredient
- Hoo Gargle Rooibos Tea Flavor Purpose
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Hoo Gargle Rooibos Tea 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 Rooibos Tea Flavor Keep out of reach of children
- Hoo Gargle Rooibos Tea Flavor Indication
- Hoo Gargle Rooibos Tea Flavor Inactive Ingredients
- Hoo Gargle Rooibos Tea Flavor Warning
- Hoo Gargle Rooibos Tea Flavor
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INGREDIENTS AND APPEARANCE
HOO GARGLE ROOIBOS TEA FLAVOR
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83367-102 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 ALANINE (UNII: OF5P57N2ZX) 0.5 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) 0.6 mg in 1 mL XYLITOL (UNII: VCQ006KQ1E) 10 mg in 1 mL SODIUM ACETATE (UNII: 4550K0SC9B) 0.5 mg in 1 mL (2-AMINO-5,6-DICHLOROQUINAZOLIN-3(4H )-YL)ACETIC ACID (UNII: 03TUA9L576) 0.5 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83367-102-02 1 in 1 PACKAGE 04/01/2023 1 NDC:83367-102-01 15 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:83367-102-04 1 in 1 PACKAGE 04/01/2023 2 NDC:83367-102-03 30 mL in 1 PACKET; Type 0: Not a Combination Product 3 NDC:83367-102-06 1 in 1 PACKAGE 04/01/2023 3 NDC:83367-102-05 50 mL in 1 PACKET; Type 0: Not a Combination Product 4 NDC:83367-102-08 1 in 1 PACKAGE 04/01/2023 4 NDC:83367-102-07 100 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(83367-102)