Otc - Active Ingredient
Activeingredient....
.Purpose
Polyhexamethylene Biguanide Hydrochloride 0.25%
Antibacterial
Toothache Spray
FDA Label NDC 87083-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd for the product Toothache (NDC 87083-012). 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, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical care for dental sufferers; relieves halitosis, periodontal & gum discomfort,
aids gum repair &conditioning.
Otc - Keep Out Of Reach Of Children
Keepoutofreachof children
if swallowed, get medical help or contacta Poison Control Center right away,
Warnings
1. This product isnot food, medicine or medical device. Do nottake orally. Keep out
2. If local irritation or discomfort occurs while using this product, please consult a
3. This is a health care product and cannot replace medicines or medical devices for treating diseases.
Dosage & Administration
Spray directlyon the mouth (toothache) for discomfort, 1-3 sprays each time, 2-3
times a day or as needed.
Inactive Ingredient
Watermelon Frost, Honeysuckde Extract,
Propolis Extract, Dandelion Extract, Gleditsia
Sinensis Thorn Extract, Honeysuckle Stem
Extract, Glycerol (Glycerin), xylitol, Food
Grade Flavor Essence, Ammonium Chloride,
Purified Water,
Indications & Usage
if you are pregnant, breastfeeding, an infant or young child, or if you have an allergy
to any ingredientof this product.
Package Label.Principal Display Panel
Labeling (87083 012 01)
* Please review the disclaimer below.
