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| Product NDC Code | 51142-003 | ||||
|---|---|---|---|---|---|
| Drug Name | All-health wound care kit |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1039699 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | ASO LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients – Antiseptic Wipes Ethyl Alcohol 66.5%
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.Directions – Antiseptic Wipes • tear open packet, remove towelette • unfold and use as a washcloth • supervise children under 6 years of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients – Antiseptic Wipes aloe vera, fragrance, purified water, triethanolamine
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.Uses – Antiseptic Wipes • Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water
Purpose
Information about the drug product’s indications for use.Purpose – Antiseptic Wipes Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.All-Health Wound Care Kit ethyl alcohol ANTISEPTIC alcohol ALCOHOL ALCOHOL ALOE VERA LEAF WATER TROLAMINE
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.Principal Display Panel – All-Health Wound Care Kit ALL-HEALTH ® WOUND CARE PRODUCTS 3-STEP WOUND CARE KIT FOR SMALL TO MEDIUM SIZED WOUNDS Essential items to support 3-STEP WOUND CARE: CLEAN COVER SECURE • For 1 IN to 3 IN wound sites • 7 – 10 days of use 40 ITEMS SEE BACK PANEL FOR KIT CONTENTS ALL-HEALTH ® is an ASO brand Distributed by ASO LLC Sarasota, Fl 34240 | www.asocorp.com Label image-01
Principal Display Panel – Antiseptic Wipes Safetec Antiseptic Towelette For Professional and Hospital Use Contents: 1 single-use, premoistened towelette Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com Label image-03
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Contents – All-Health Wound Care Kit ALL-HEALTH ® WOUND CARE PRODUCTS STEP 1 CLEAN 10 GAUZE PADS To clean wound, apply medication, or use a secondary dressing. 4 IN x 4 IN (101 mm x 101 mm) (Made in China) 10 ANTISEPTIC WIPES Use to clean hands if soap and water are not available. Use to 4.75 IN x 7.75 IN (120 mm x 196 mm)clean healthy skin around the wound site to prevent contamination. (Made in USA) Gently clean the wound using a sterile Gauze Pad with mild soap and water. Carefully dry the affected area and apply medication if necessary (not included). Discard the used pad. STEP 2 COVER 12 NON-STICK * PADS Primary dressing protects and absorbs for low to moderately 3 IN x 4 IN (76 mm x 101 mm) draining wounds. (Made in China) 4 TRANSPARENT DRESSINGS Protect wound and/or sutures from moisture and environment. 2.36 IN x 2.75 IN (59 mm x 69 mm) (Made in China) Carefully cover the wound with a Non-Stick * Pad to help absorb fluid. STEP 3 SECURE 3 ROLLED GAUZE Secure dressings for areas that bend or flex. 4 IN x 2.5 YDS (101 mm x 2.28 m) (Made in China) 1 PAPER TAPE Secure dressings for areas that do not bend or flex. 1 IN x 10 YDS (25 mm x 9.14 m) (Made in China) Secure pad with Rolled Gauze, taping the ends if necessary. * Will not adhere to sutures, staples, or adhesive wound closures. Ideal for low to moderately draining wound. Antiseptic Wipes: Keep these and all drugs products out of the reach of children. Transparent Dressings: Do not use as a primary dressing on moderately to heavily draining wounds.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use – Antiseptic Wipes in the eyes. If this happens, rinse thoroughly with water.
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 – Antiseptic Wipes If swallowed get medical help or contact a 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 Safety Information – All-Health Wound Care Kit 3-STEP WOUND CARE KIT FOR SMALL TO MEDIUM SIZED WOUNDS For wound sites ranging in size from 1 INCH - 3 INCH which may include: • Common Wounds • Lacerations • Abrasions • Minor burns Dressings may be cut or folded for specific wound size. Not made with natural rubber latex. Gauze Pads, Non-Stick Pads, Transparent Dressings, and Rolled Gauze are sterile unless individual wrapper has been opened or damaged. Paper Tape and Antiseptic Wipes are non-sterile. Gauze Pads and Rolled Gauze are Rayon-polyester bend. Consult with your medical professional for specific treatment of wound site and proper dressing change procedures. WARNING: In case of deep puncture wounds, serious burns, or signs of infection, consult a physician. Single use only.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor – Antiseptic Wipes if irritation or redness develop and persists for more than 72 hours
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 – Antiseptic Wipes For external use only Flammable: keep away from fire or flame Do not use – Antiseptic Wipes in the eyes. If this happens, rinse thoroughly with water. Stop use and ask a doctor – Antiseptic Wipes if irritation or redness develop and persists for more than 72 hours Keep out of reach of children – Antiseptic Wipes If swallowed get medical help or contact a 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