FDA Label for Medifresh Hand Skin Antiseptic Disinfectant Wet Wipes
View Indications, Usage & Precautions
Medifresh Hand Skin Antiseptic Disinfectant Wet Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Kardesler Ucan Yaglar Sanayi Anonim Sirketi. 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) (80%, (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Benzalkonium Chloride (0.1% w/w).
- Glycerol (0.2% w/w).
- Tocopheryl Acetate (0.05% w/w)
- Propylene Glycol (0.2% w/w).
- Aloe Barbadensis Extract (0.02% w/w)
- Citric acid (0.04% w/w)
- 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)
Alcohol 80% w/w
Benzalkonium Chloride 0.1% w/w .
Purpose: Antiseptic
Purpose
Antiseptic, Hand & Skin Sanitizer
Use
Skin should be rubbed vigorously with the wet wipe. No need to rinse after usage. Allow skin to dry without wiping. For adults and children 2 years and over.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
do not use
- as baby wipe
- on open skin wounds
- if you are allergic to any other ingredient.
Otc - When Using
When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or allergic reaction occurs.
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
- Open contaniner plastic cover. Tear off aluminum cover. From center of wipe roll, pull up wipe corner; Twist wipe corner from the center plastic cap, thread through the hole. Pull through about one inch. Replace plastic cover. Pull out wipes as needed and snap off at 90 angle. Wipe skin,hands, wrist and elbow ensuring wetting completely. Do not rinse after usage. Keep center cap closed to prevent moisture loss. Discard properly after use.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store in dry and cool place and away from oxidizers.
- May discolor some fabrics, harmful to wood finishes and plastics.
Inactive Ingredients
Aqua, Glycerol, Propylene Glycol, Parfum, Tocopheryl Acetate, Citric acid, Aloe Barbadensis Extract
Package Label - Principal Display Panel
80 PCS NDC: 86937-002-02
200 PCS NDC: 86937-002-01
* Please review the disclaimer below.