Active Ingredient
Ethyl Alcohol 70% v/v
Hand Sanitizer
FDA Label NDC 51384-002
11 label sections · Submitted to the FDA by Botanicals Internacional S.a. De C.v · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Botanicals Internacional S.a. De C.v for the product Hand Sanitizer (NDC 51384-002). 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, keep out of reach of children, purpose, warnings, directions, uses, stop use and ask a doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose
Antiseptic
Warnings
Warnings
- Flammable. Keep away from fire or flame.
- For external use only.
Directions
Direction:
- Put enough product in your palm to cover hands and rub hands together briskly until dry.
- Children under 6 years old should be supervised when using this product.
Uses
Use: hands sanitizer to help decrease bacteria on the skin
Stop Use And Ask A Doctor
Stop use and ask a doctor if irritation or rash appears and lasts.
When Using This Product
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Inactive Ingredients
Inactive ingredients:
water 28%, glycerin 1%, carbopol 940 0.50%,TEA 85 0.50%,
Other Information
Store below 110 oF (43 oC)
May discolor certain fabrics
Principal Display Panel
NDC: 51384-002-01
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