Insta-shield
FDA Label NDC 78829-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Four Fathers Distillery Llc for the product Insta-shield (NDC 78829-101). 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 drug facts, active ingredient(s):, purpose, use(s):, warning, directions:, other information:, inactive ingredient(s):, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S):
Alcohol (ethanol) 65%.
Purpose
Antiseptic
Use(S):
Helps reduce bacteria that can potentially become disease.
Warning
For external use only. FLAMMABLE: Keep away from heat and flame.
Do NOT USE: On children less than 2 months of age.
Do NOT USE: On open skin wounds.
Keep out of eyes, ears, and mouth. Stop use if rash or irritation occurs. This could be a sign of a serious condition.
Directions:
Place enough product on hands to cover all surfaces, rub together until dry.
Supervise children under 6 years of age to prevent swallowing.
Other Information:
Store between 59-86°F. DO NOT store in heat above 105°F. May discolor some fabrics. Harmful to wood surfaces and plastics.
Inactive Ingredient(S):
Glycerin, Aloe Barbadensis Leaf Juice, Hydroxyethylcellulose, Purified Water, Essential Oils
Packaging
Dropgel (Instgel)
* Please review the disclaimer below.
