FDA Label for Tinfu Isopropyl Alcohol Prep Pads
View Indications, Usage & Precautions
Tinfu Isopropyl Alcohol Prep Pads Product Label
The following document was submitted to the FDA by the labeler of this product Shandong T&f Medical Technology Co., 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
Use
For preparation of the skin prior to injection.
Warnings
For external use only. Flammable,keep away from fire or flame.
Do Not Use
- with electrocautery procedures.
Otc - When Using
When using this product do not get into eyes. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites or serious burns, consult a doctor. use only in a well ventilated area.
Otc - Stop Use
Stop use and ask a doctor if irritation and redness develops.
Females & Males Of Reproductive Potential
If pregnant or breastfeeding ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply to skin as needed.
- Discard after single use.
Other Information
- Store at room temperature 15-30C (59-86F)
Inactive Ingredients
Water
Package Label - Principal Display Panel
NDC: 82167-000
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