Divas
FDA Label NDC 51444-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jmd All Star Impex Inc for the product Divas (NDC 51444-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient
Hydrogen peroxide 3%

Otc - Purpose

PurposeFirst aid antiseptic/oral debriding agent

Indications & Usage

Uses• first aid to help prevent risk of infection in minor cuts ,scrapes and burns • aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth

Warnings

WarningsFor external use onlyDo not use  • in the eyes or apply over large areas of the body  • more than one week

Otc - Ask Doctor

Consult a doctor before use if you haveanimal bites or serious burns, deep or punctured wounds

Otc - Stop Use

Stop use and consult a doctor if  • the condition persists or gets worse• sore mouth symptoms do not improve in a week • pain redness or irritation persists or if you develop fever ,rash or swelling

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIn case of an accidental ingestion, seek professional assistance or contact a poison control center immediately

Dosage & Administration

DirectionsFirst aid antiseptic                                                                                                 oral debriding agent (oral rinse)•clean affected area                                                                                               Adults and children 2 years and over•apply a small amount of this product on the affected area 1-3 times a day                 • mix with an equal amount of water • may be covered with a sterile bandage                                                                   • swish around in the mouth over affected area for at least 1 minute then spit out                                                                                                                             • use up to 4  times daily after meals and at                                                                                                                                bedtime or as suggested by a doctor or dentist•let dry first before using bandage for children under 2 years: consult a dentist or a doctorchildren under 12 years should be supervised in the use of this product

Other

Other informationKeep tightly closed in a dark place at a controlled room temperatureDo not shake the bottle. Keep away from face when opening

Inactive Ingredient

Inactive ingredientspurified water

Package Label.Principal Display Panel

Package Label

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