Statement Of Identity
Hand Sanitizer Hand Wipe
Sole Wipe
FDA Label NDC 81813-503
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Soul Wipe, Inc. for the product Sole Wipe (NDC 81813-503). 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 statement of identity, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, 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
Otc - Active Ingredient
Ethyl Alcohol 70% v/v
Otc - Purpose
Antiseptic
Indications & Usage
Hand Sanitizer to help reduce bacteria on the skin
Warnings
Flammable. Keep away from sources of heat, fire or flame
For external use only
When using this product, do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if irritation or redness develops and lasts
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
Otc - When Using
Avoid contact with eyes. If so flush with plenty of water for 15 minutes immediately
Otc - Ask Doctor
Stop use and ask a doctor if irritation develops ans lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.
Directions
Use one wipe per pair of hands to avoid cross contamination
Seal after each use
Avoid contact with eyes. If so, flush with prenty of water for 15min immediately
Supervise children under 6 years of age when using this product to avoid swallowing
Inactive Ingredient
Water (aqua), Glyserin, Aloe Barbadensis leaf juice, Calendula Offincinalls (Marigold) flower extract, Camella Sinensis (white tea) leaf extract, Citrus Aurantium (Bergamont) Oil, Matricaria Recultita (Chamomile) flower extract, PogostemonCablin (Patchouli) oil, rock chrystals
Storage And Handling
Flammable. Keep away from sources of heat, fire or flame
Seal after each use
* Please review the disclaimer below.
