FDA Label for Cotton Soft
View Indications, Usage & Precautions
Cotton Soft Product Label
The following document was submitted to the FDA by the labeler of this product Sepa Mensucat Sanayi Ve Ticaret 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%, 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.
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%. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
For Hand sanitizing to decrease bacteria and germs on skin
Apply topically to skin to help prevent cross contamination
Dries in seconds
Warnings
For external use only. Harmful if shallowed
Highly Flammable.
Keep away from heat or flame.
Avoid contact with open or exposed skin wounds
Do Not Use
- Do not use as baby wipes
- Do not flush down the toilets
- Do not use in or contact the eyes
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 skin irritation and sensitivity develops or increases.
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 skin irritation and sensitivity develops or increases.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- Lift the tab on the top of the lid to open
- Open moisture seal film package before use.
- Pull out first wipe through the dispensing center of the canister. Next sheets pops up automatically.
- Close the lid to retain moisture.
- Wipe down with this product. Let air dry.
Other Information
- Store at room temperature between 15-30C (59-86F)
- Lot No., manufacture date and expiration date can be found on package.
Inactive Ingredients
Purified water
Hand Sanitizing Wipes-Package Label - Principal Display Panel
Hand Sanitizing wipes 50 pcs NDC: 81406-001
Hand Sanitizing Wipes- 50 Pcs
Hand Sanitizing Wipes- 50 pcs
NDC: 81406-001-50
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