FDA Label for Alcohol Disinfectant
View Indications, Usage & Precautions
Alcohol Disinfectant Product Label
The following document was submitted to the FDA by the labeler of this product Qingdao Maixing Biotechnology 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:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- 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 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Suitable for sterilization and disinfection of the surface of the object and the complete skin of the human body.
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.in case of contact with eyes,flush thoroughly with water.
Avoid contact with broken skin.
Do not inhale or ingest.
Otc - Stop Use
Stop use and ask a doctor if irritation and redness develop condition persists for more tahn 72 hours.
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
To dean,disinfect and deodorize.
this product is for extermal use.apply this product to skin,hands and general objects
this product is not a substitute for drugs or medical devices
use with caution;infants, pregnant women and breastfeeding women
keep out of reach of children,children must supervised in use of this product
Other Information
- do not store above 105.F
- may discolor some fabrics
- harmful to wood finisher and plastics
Inactive Ingredients
water
Package Label - Principal Display Panel
50 mL NDC: 50ml
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