FDA Label for Aktive Sanitizing Wipes
View Indications, Usage & Precautions
Aktive Sanitizing Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Hall Global 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:
- Ethyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerin (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water\
- Fragrance
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)
Ethyl Alcohol 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Use wipes on hands, skin, or surfaces to decrease bacteria, recomended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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 thoroughtly with product, and allow to dry. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age should be supervised when using this product.
Other Information
- Store between 60-90 F (15-30C)
- Avoid freezing and excessive heat above 104 F(40C). May discolor some fabrics. Harmful to wood finishes and plastics.
Inactive Ingredients
glycerin, hydrogen peroxide, purified water, fragrance
* Please review the disclaimer below.