Active Ingredient(S)
Ethyl Alcohol 60%
Instant Hand Sanitizer
FDA Label NDC 70483-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jean Pierre Inc. for the product Instant Hand Sanitizer (NDC 70483-009). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
Helps reduce bacteria on skin. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from fire or flame.
Do Not Use
do not use in or near tile eyes
Otc - When Using
When using this product do not use in or near tile eyes. In case of contact, rinse eyes thoroughly with water. Do not use on open skin wounds. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Apply enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product.
Other Information
Do not store in temperature over 118°F.
Inactive Ingredients
Water, Carbomer, Triethanolamine, Fragrance, May contain: Red 4 (Cl 14700), Red 33 (Cl 17200), Ext. Violet 2 (Cl160730), Blue 1 (Cl 142090), Yellow 5 (Cl 19140), Glycerine, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice.
Package Label - Principal Display Panel
2 (2)
3 (01602 Harmon Handsanitizer 2oz Warmvanilla Label Fda 5.18.20 Ol.ai)
1 (1)
4 (01602 Harmon Handsanitizer 2oz Pomegranate Label Fda 5.18.20 Ol.ai)
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