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Product NDC Code | 71584-0111 | ||||||||||||||
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Drug Name | Antibacterial bandages |
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Type | Brand | ||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||
Dosage Form | DRESSING | ||||||||||||||
RxCUI drug identifier | 1038558 | ||||||||||||||
Application Number | M003 | ||||||||||||||
Labeler Name | Guangdong Comfort Medical Products Co., Ltd. | ||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Benzalkonium Chloride 0.13%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Dosage and administration Apply a sterile bandage on the affected area 1 to 3 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USE First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.ANTIBACTERIAL BANDAGES Benzalkonium Chloride WATER BENZALKONIUM CHLORIDE BENZALKONIUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Label principal display panel NDC 71584-0111-1 ANTIBACTERIAL BANDAGES Drug Facts ACTIVE INGREDIENTS Benzalkonium Chloride 0.13% Purpose Antiseptic USE First aid to help reduce the risk of infection in minor cuts, scrapes, and burns. WARNINGS For external use only. Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than one week unless directed by a physician. In case of deep or puncture wounds, animal bites, or serious burn, consult a physician. Keep out of reach of children. if swallowed get medical help or contact Poison control Center right away. DIRECTIONS Clean and dry the affected area. Apply a sterile bandage on the area 1 to 3 times daily. Other Information: not intended for use on delicate or sensitive skin. INACTIVE INGREDIENT Water 71584-0111-1 71584-0111-2 71584-0111-3 71584-0111-4 71584-0111-5 71584-0111-6 equate-5 equate-4 equate-3 equate-2 equate-1
Instructions for use
Information about safe handling and use of the drug product.DIRECTIONS Clean and dry the affected area. Apply a sterile bandage on the area 1 to 3 times daily.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children Keep out of reach of children. if swallowed get medical help or contact Poison control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Not intended for use on delicate or sensitive skin.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS For external use only. Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a physician. In case of deep or puncture wounds, animal bites, or serious burn, consult a physician. Keep out of reach of children. if swallowed get medical help or contact Poison control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API