Label: LUXURY ANTISEPTIC- hydrogen peroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76772-023-17 - Packager: TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 10, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- INDICATIONS & USAGE
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Warnings
For external use only.
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.
- stop use
- Ask doctor
- Do not use
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DOSAGE & ADMINISTRATION
Directions For use as a first aid antiseptic:
- Clean affected area.
- apply small amount of product on affected area 1-3 times a day.
- may be covered with a sterile bandage.
- For use as an oral debriding agent (oral rinse):
- adults and children 2 years of age and over
- mix with an equal amount of water.
- swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.
- use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
- children under 12 years should be supervised in the use of this product.
- children under 2 years of age: consult a dentist or doctor.
- Other information
- INACTIVE INGREDIENT
- Packaging
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INGREDIENTS AND APPEARANCE
LUXURY ANTISEPTIC
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76772-023 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76772-023-17 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/10/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/10/2021 Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570) Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570) Establishment Name Address ID/FEI Business Operations TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI 533120570 manufacture(76772-023)