FDA Label for Seven Three Hand Sanitizer
View Indications, Usage & Precautions
Seven Three Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Seven Three Distilling Company, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
- Methacrylic Acid - Ethyl Acrylate Copolymer (5.5% v/v)
The firm does add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Alcohol 80%. Purpose: Antiseptic
Hydrogen Peroxide <1%. Purpose: Antiseptic
Use
- For handwashing to decrease bacteria on the skin
- recommended for repeated use
Warnings
For external use only - hands.
Flammable. Keep away from heat or flame.
When usting this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
Stop use and ask a doctor if skin irritation develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- for children under 6, use only under adult supervision
- not recommended for infants
- avoid contact with broken skin
Otc - When Using
When using this product keep out of eyes. In case of contact with eyes, flush thoroghly with water.
Avoid contact with broken skin.
Do not ingest or inhale.
Stop use and ask a doctor if skin irritation develops.
Keep out of reach of children. If swallowed, get medical help or help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if skin irritation develops.
Otc - 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.
Directions
- Wet hands thoroughly with product and allow to dry without wiping.
- For childres under 6, use only under adult supervision
- Not recommended for infants
Other Information
- Do not store above 105°F
- May discolor some fabrics
- harmful to wood finishes and plastics
Inactive Ingredients
water, glycerin, isopropyl, carbopol, lemongrass oil
Purpose
Antiseptic, Hand Sanitizer
Package Label - Principal Display Panel
128 FL OZ (3785ML) 75219-7337-5
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