FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Reneotech Inc. 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:
- Isopropyl Alcohol (75%, 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.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Ethlyl Alcohol 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Uses
- To decrease bacteria on the skin that could cause disease
- Recommended for repeat use
Warnings
For external use only. Flammable. Keep away from fire or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product
- Keep out of eyes, incased of contact with eyes, flush thoroughly with water
- Avoid contact with broken skin
- Do not inhale or ingest
Otc - Stop Use
Stop use and ask a doctor if
- Irritation and redness develop
- Condition persists for more than 72 hours
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
Directions
- Wet hands thoroughly with product and allow to dry without wiping
- For Children 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 woodfinishes and plastics
Inactive Ingredients
Deionized Water, Polyacrylic Acid, Wormwood Leaf Extract, Dandelion Extract, Aminomethyl Propanol.
Recent Major Changes
- usage
- warnings
Package Label - Principal Display Panel
- 59.1471 ml NDC: 79991-001-05
- 236.588 ml NDC: 79991-001-08
- 480 ml NDC: 79991-001-10
- 946.353 ml NDC: 79991-001-12
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