FDA Label for Servclean Sanitizing Wipes
View Indications, Usage & Precautions
Servclean Sanitizing Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Charlotte Products Ltd.. 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)
Isopropyl Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Personal hand sanitizing wipe to help reduce bacteria that potentially can cause disease.
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
When using this product 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 right away.
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
Open the plastic tab at the front of the bottle. Pull up wipe and replace plastic cap. Always snap lid securely shut between uses to prevent moisture loss.
• Take one wipe and rub onto hands to cover all surfaces. Let hands air dry.
• NOT intended for intimate hygiene. Dispose of used wipes in trash.
• Supervise children under 6 years of age when using this product to avoid swallowing.
Storage
Store at room temperature in a cool, dry place, avoid direct sunlight. Store below 110°F (43°C). Do not reuse empty canister.
Inactive Ingredients
purified water
Package Label - Principal Display Panel
70 Count NDC: 64646-399-01
180 Count NDC: 64646-399-02
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