Antiseptic Cloth
FDA Label NDC 61010-2017

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Antiseptic (NDC 61010-2017). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding contents – all-health wound care kit, other safety information – all-health wound care kit, active ingredients – antiseptic wipes, purpose – antiseptic wipes, uses – antiseptic wipes, warnings – antiseptic wipes, do not use – antiseptic wipes, stop use and ask a doctor – antiseptic wipes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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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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