产品详细介绍

【产品名称】医用退热凝胶

【型号规格】20g、25g、30g、50g、80g、100g、120g、150g、200g、250g。

【产品性能结构】产品由降温物质和PET瓶组成，降温物质由卡波姆、甘油、三乙醇胺、山梨酸钾、丙二醇和水组成。降温物质不含有发挥药理学、免疫学或者代谢作用的成分，不包含《第一类医疗器械产品目录》附录所列成分。非无菌产品。

【适用范围】用于发热患者的局部降温。仅用于体表完整皮肤。

【使用方法】外用，打开盖子，取黄豆大小凝胶于额头、腋下或腹股沟处皮肤表面来回涂抹，每个部位可反复涂抹3至4次。

【禁忌症】对本品过敏者禁用，高过敏体质者慎用。

【注意事项】

1、请将本品放在儿童不能接触的地方。

2、勿涂于破损皮肤部位；使用时应避免接触眼睛、口腔等部位，如不慎接触，应立即用清水冲洗。

3、使用中若有轻微不适或偶有皮肤表皮发红，停用即可自行恢复；严重过敏者请就医处理。

4、瓶底如有少量沉淀为正常现象，不影响使用。

5、儿童、孕妇、哺乳期妇女等特殊人群应在医生指导下使用。

【储存条件】室温储存，打开后请尽快使用。

【有效期】二年。

【备案人名称】山东科诺德生物医药科技有限公司

【售后服务机构】山东科诺德生物医药科技有限公司

【产品备案凭证编号】鲁泰械备20260004

【生产备案凭证编号】鲁枣食药监械生产备20190005号

【产品技术要求编号】鲁泰械备20260004

Medical Cooling Gel

Product Specifications

20g, 25g, 30g, 50g, 80g, 100g, 120g, 150g, 200g, 250g

Product Performance and Composition

The product consists of cooling substance and PET bottle. The cooling substance is composed of carbomer, glycerin, triethanolamine, potassium sorbate, propylene glycol and water. The cooling substance contains no ingredients exerting pharmacological, immunological or metabolic effects, and does not include ingredients specified in the appendix of the Catalogue of Class I Medical Devices.

Non-sterile product.

Intended Use

For local cooling of febrile patients. For use only on intact body surface skin.

Instructions for Use

For external use. Open the cap, take a soybean-sized amount of gel and apply evenly on the skin surface of forehead, armpits or groin, and repeat application 3 to 4 times for each area.

Contraindications

Prohibited for patients allergic to this product. Use with caution for people with severe allergic constitution.

Precautions

1. Keep out of reach of children.

2. Do not apply onto broken skin. Avoid contact with eyes, mouth and other areas during use. Rinse immediately with clean water in case of accidental contact.

3. Mild discomfort or occasional epidermal redness may occur during use; symptoms will resolve spontaneously after discontinuation. Seek medical treatment in case of severe allergy.

4. A small amount of sediment at the bottom of the bottle is normal and does not affect use.

5. Special populations including children, pregnant women and lactating women shall use the product under the guidance of physicians.

Storage Conditions

Store at room temperature. Use promptly after opening.

Shelf Life

2 years

Registrant

Shandong Kenuode Biomedical Technology Co., Ltd.

After-sales Service Provider

Shandong Kenuode Biomedical Technology Co., Ltd.

Medical Device Filing Certificate No.

Lu Tai Medical Device Filing 20260004

Manufacturing Filing Certificate No.

Lu Zao Food and Drug Administration Medical Device Manufacturing Filing 20190005

Product Technical Requirement No.