Otc - Active Ingredient
Active Ingredient - Ethyl Alcohol 62%
Bubble Gum
FDA Label NDC 50157-116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brands Internation Corp for the product Bubble Gum (NDC 50157-116). 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 - keep out of reach of children, user safety warnings, otc - ask doctor/pharmacist, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose - Antiseptic
Indications & Usage
Use
- to decrease bacteria on the skin and clean hands
- recommeded for repeated use
Warnings
Warnings
for external use only
Flammable, keep away from fire or flame
Otc - Keep Out Of Reach Of Children
Keep out of children. If accidently swallowed, get medical helpor contact a Poison Control Center right away
User Safety Warnings
Do not get into eyes, If contact occurs, rinse thoroughly with water
Other information
- may discolor certain fabrics or surfaces
- do not store above 110 F (43 C)
Otc - Ask Doctor/Pharmacist
Discontinue Use if irritation or redness develops, If irritation persists for more than 72 hours, consult a doctor
Dosage & Administration
Directions
- apply to hands until thoroughly wet
- rub vigorously until dry
- supervise children in the use of this product
Inactive Ingredient
Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Prpanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Heilanthus Annuus) Seed Extract, Grapefruit (Citrus Grandis) Seed Extract, yellow 6 (Cl 15985) Red 40 (Cl 16035)
* Please review the disclaimer below.
