Medical Recombinant Type Iii Humanized Collagen Repair Patch
FDA Label NDC 84345-443

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hunan Yinhuatang Pharmaceutical Technology Co., Ltd for the product Medical Recombinant Type Iii Humanized Collagen Repair Patch (NDC 84345-443). 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 active ingredients, purpose, use, directions, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Glycerin   21%

Purpose

Skin Protectant

Use

For the care of non-chronic wounds (such as superficial wounds, post-surgical suture wounds, mechanical wounds, small wounds, abrasions, cut wounds, puncture wounds, Ⅰ or Ⅱ degree burn wounds, wounds after laser/photon/fruit acid peeling/plastic surgery), to provide a micro-environment for wound healing and assist in the improvement of post-wound healing hyperpigmentation; for the early stages of acne after wound healing. Suitable for the early stage of acne healing and as an adjunctive treatment for superficial scars.

Directions

One patch at a time for 15-25 minutes.

Warnings

External Use Only

Do Not Use

  • Those who have a history of allergy to topical collagen products and those who are sensitive to external use of foreign proteins are prohibited from using this product.
  • Those with acne combined with severe infection and pustules should not use this product before the inflammation is effectively controlled.
  • This product should not be used for large-area skin damage. 
  • Pregnant and lactating women should use it with caution.

When Using This Product

  • This product is for one-time use only and is not allowed to be reused.
  • Do not use if the packaging is damaged.
  • This product rarely causes allergic reactions. If an allergic reaction occurs, stop using this product immediately.
  • For patients with acne combined with severe infection and pustules, it is recommended to control the infection before using this product, but topical anti-infective drugs should be used at different times from this product.
  • Please read the instructions carefully before use and use the product within the validity period. It is prohibited to use it after the validity period.
  • This product is in long-term contact with the skin, and the cumulative use time should not exceed 30 days.

Stop Use And Ask A Doctor If

■ condition worsens
■ redness is present
■ irritation develops
■ symptoms persist for more than 7 days or clear up and occur again within a few days
■ you experience signs of skin injury, such pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Manufactured By Hunan Yihuatang Pharmaceutical Co., Ltd.Building 17, Phase 3, Standardized Factory Building, Junshan Industrial Park, Liulinzhou Street Off Yueyang, Hunan, China 414005Phone Number: (86)400-0168755

Made in China

Inactive Ingredients

D-(+)-Trehalose Dihydrate, Carbomer 980, Xanthan Gum, Butylene Glycol, Trolamine, Purified Water

Package Label

Image Description (Carton)

Image Description (Carton)

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