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  5. Label Information: All-health Wound Care Kit

FDA Label for All-health Wound Care Kit

View Indications, Usage & Precautions

Table of Contents

    1. CONTENTS – ALL-HEALTH WOUND CARE KIT
    2. OTHER SAFETY INFORMATION – ALL-HEALTH WOUND CARE KIT
    3. ACTIVE INGREDIENTS – ANTISEPTIC WIPES
    4. PURPOSE – ANTISEPTIC WIPES
    5. USES – ANTISEPTIC WIPES
    6. WARNINGS – ANTISEPTIC WIPES
    7. DO NOT USE – ANTISEPTIC WIPES
    8. STOP USE AND ASK A DOCTOR – ANTISEPTIC WIPES
    9. KEEP OUT OF REACH OF CHILDREN – ANTISEPTIC WIPES
    10. DIRECTIONS – ANTISEPTIC WIPES
    11. INACTIVE INGREDIENTS – ANTISEPTIC WIPES
    12. PRINCIPAL DISPLAY PANEL – ALL-HEALTH WOUND CARE KIT
    13. PRINCIPAL DISPLAY PANEL – ANTISEPTIC WIPES

All-health Wound Care Kit Product Label

The following document was submitted to the FDA by the labeler of this product Aso Llc. 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.

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.


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.


Active Ingredients – Antiseptic Wipes



Ethyl Alcohol 66.5%


Purpose – Antiseptic Wipes



Antiseptic


Uses – Antiseptic Wipes



  • •Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water

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


Directions – Antiseptic Wipes



  • •tear open packet, remove towelette
  • •unfold and use as a washcloth
  • •supervise children under 6 years of age

Inactive Ingredients – Antiseptic Wipes



aloe vera, fragrance, purified water, triethanolamine


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

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    Label


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

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Label


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