Zero Hand Sanitizer
FDA Label NDC 74772-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Formula for the product Zero Hand Sanitizer (NDC 74772-010). 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, inactive ingredient, purpose, warnings, keep out of reach of children, uses, directions, package label - zero hand sanitizer 60ml spray, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Active ingredients:
Rosmarinus Officinalis (Rosemary) Leaf Extract 1%
Chamomilla Recutita (Matricaria) Flower Extract1%
Melaleuca Alternifolia (Tea Tree) Leaf Extract 1%
Lavandula Angustifolia (Lavender) Flower Extract 1%

Inactive Ingredient

Inactive ingredients:

Water, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Scutellaria Baicalensis Root Extract, Rhus Semialata Extract, Terminalia Chebula Fruit Extract, Morus Alba Bark Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Butylene Glycol, Boswellia Serrata Extract, Centella Asiatica Extract, Camellia Sinensis Leaf Extract, Actinidia Arguta Fruit Extract, Citrus Paradisi (Grapefruit) Seed Extract, Chamaecyparis Obtusa Water, Flavor

Purpose

Purpose: SANITIZER

Warnings

Warnings:

1.Do not use the product on the following areas:
Eyes, mouth, and damaged skin (irritation may occur)
2.If you experience any of the following symptoms, stop using the product immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms (e.g. rash, erythema, itching and edema)
2) Skin irritation symptoms
3. Other precautions
1) For external use only. (Do not swallow. If swallowed, vomit and consult a doctor or pharmacist)
2) Avoid contact with eyes. If in contact, wash with clean water and consult a doctor or pharmacist.
3) Do not use sealed bandages, cast bandages or packs as they may cause irritation.
4) Do not use this medicine for anal or vaginal areas or hot packs as it may cause irritation.
5) Use only for the intended purpose.
4.Precautions for storage
1) Keep away from direct sunlight and do not expose the product to heating devices or flame.
2) Keep out of reach of children and go to the hospital immediately if swallowed.
3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.
4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.
Dust or foreign substances may get on the product while using it.

Keep Out Of Reach Of Children

Keep out of reach of children and go to the hospital immediately if swallowed.

Uses

Uses:

Disinfection of hands and skin

Directions

Directions (for Gel type)

Take an appropriate amount on your hands and rub thoroughly to dry.

Directions (for Spray type)
Spray the appropriate amount on your hands and rub thoroughly.

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