Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on February 23, 2023 by The Health Master
FAQs – on Mouthwash
Mouthwash, also called oral rinse, is a liquid product used to rinse your teeth, gums, and mouth.
It usually contains an antiseptic to kill harmful bacteria that can live between your teeth and your tongue.
Some people use mouthwash to fight against bad breath, while others use it to try to prevent tooth decay.
1. Q: Does mouthwash with a recommended use to treat bad breath, plague, gum issues, and so on, fall under the definition of “drug” under the D&C Act 1940?
Ans: Mouthwash is a “drug” under section 3b(i) of the D&C Act 1940.
2. Q: Under which category does “Mouthwash” fall as far as Schedule M is concerned?
Ans: It is an external preparation and can be manufactured in the external preparation section as per the condition given in Schedule M, Part 1-D, and a separate area should be provided in the section to avoid mixing of products to be manufactured for internal use.
3. Q: Whether any special provisions exist for packings of “Mouthwash” under Rule 105?
Ans: No, such products can be manufactured in any pack size.
4. Q: Whether Mouthwash are covered under schedule H drugs?
Ans: The composition of mouthwash determines its inclusion under Schedule H. Mouthwash containing schedule H drugs/ingredients is covered under schedule H drugs.
5. Q: What is the therapeutic use of mouthwash?
Ans: Gargle of the buckle buccal cavity, cleansing of buccal/overall cavity, to provide freshness in the mouth, etc.
6. Q: Whether this Mouthwash attracts Legal Metrology (Packed Commodities) Rules 2011?
Ans: No, as it is exempted from the Legal Metrology (Packed Commodities) Rules 2011.
7. Q: Is the definition of Mouthwash given in the Drug and Cosmetic Act?
Ans: The definition of mouthwash was not defined under the Act, but as per its clinical use, it is a drug.
Note: Now, Mouthwash and Breath Spray come under the List of categories of cosmetics for import in the Fourth Schedule of Cosmetics Rules 2020 at Sr. Nos. 76 and 77, respectively, vide notification No. GSR 763(E) dt 15-12-2020.
How to use mouthwash
Product directions may vary according to which mouthwash brand you use. Always follow package instructions over what you read in an article.
Here are the basic instructions for most kinds of mouthwash.
1. Brush your teeth first
Start by thoroughly brushing and flossing your teeth.
If you’re brushing with fluoride toothpaste, wait a while before using mouthwash. The mouthwash can wash away the concentrated fluoride in the toothpaste.
2. How much mouthwash to use
Pour your oral rinse of choice into the cup provided with the product or a plastic measuring cup. Use only as much mouthwash as the product instructs you to use. It’s typically between 3 and 5 teaspoons.
3. Ready, set, rinse
Empty the cup into your mouth and swish it around. Don’t swallow it. Mouthwash isn’t meant for ingesting, and it won’t work if you drink it.
While you’re rinsing, gargle for 30 seconds. You may want to set a watch or try to count to 30 in your head.
4. Spit it out
Spit the mouthwash out into the sink.
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