说明与适用边界
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spl product data elements
EBSL-5 Lidocaine Hydrochloride Burn Jel Lidocaine Hydrochloride CARBOMER HOMOPOLYMER TYPE C GLYCERIN PROPYLENE GLYCOL METHYLPARABEN TEA TREE OIL DIAZOLIDINYL UREA TROLAMINE OCTOXYNOL-9 CARBOMER HOMOPOLYMER TYPE B PROPYLPARABEN EDETATE DISODIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS Burn Jel Lidocaine Hydrochloride CARBOMER HOMOPOLYMER TYPE C GLYCERIN PROPYLENE GLYCOL METHYLPARABEN TEA TREE OIL DIAZOLIDINYL UREA TROLAMINE OCTOXYNOL-9 CARBOMER HOMOPOLYMER TYPE B PROPYLPARABEN EDETATE DISODIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS
活性成分 / Active ingredient
Active ingredient Lidocaine HCl 2.0 %
用途 / Purpose
Purpose External analgesic
适应证 / Indications and usage
Uses for the temporary relief of pain associated with minor burns
警告 / Warnings
Warnings For external use only Do not use on large areas of the body on broken, blistered or oozing skin When using this product avoid contact with eyes Stop use and ask a doctor if conditions worsens symptoms persist for more than 7 days symptoms clears up and occur again in a few days Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
禁用事项 / Do not use
Do not use on large areas of the body on broken, blistered or oozing skin
使用中 / When using
When using this product avoid contact with eyes
停用事项 / Stop use
Stop use and ask a doctor if conditions worsens symptoms persist for more than 7 days symptoms clears up and occur again in a few days
儿童安全 / Keep out of reach of children
Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
用法用量原文 / Dosage and administration
Directions adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily spread a thick even layer over affected skin children under 2 years of age: consult a doctor
spl unclassified section
Other information store at room temperature do not use packeet if opened or torn you may report a serious adverse reaction to this product to 800-275-3433
MEDICAL DEVICES 2 4" x 4" Burn Dressing 2 4" x 16" Burn Dressing 1 8" x 18" Burn Dressing 1 12" x 16" Face Mask 2 3" Rolls of Gauze 1 Pair of Scissors
辅料 / Inactive ingredients
Inactive ingredients triethanolamine, meleleuca alternifolia (tea tree) leaf oil, glycerin, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, carbomer, octoxynol-9, acrylates C/10-30 alkyl acrylate, disodium EDTA
questions
Questions 1-800-275-3433 www.waterjel.com
spl unclassified section table
<table width="50%"> <caption>MEDICAL DEVICES </caption> <tbody> <tr> <td> 2</td> <td> 4" x 4" Burn Dressing</td> </tr> <tr> <td> 2</td> <td> 4" x 16" Burn Dressing</td> </tr> <tr> <td> 1</td> <td> 8" x 18" Burn Dressing</td> </tr> <tr> <td> 1</td> <td> 12" x 16" Face Mask</td> </tr> <tr> <td> 2</td> <td> 3" Rolls of Gauze</td> </tr> <tr> <td> 1</td> <td> Pair of Scissors</td> </tr> <tr> <td> </td> <td> </td> </tr> </tbody> </table>
package label principal display panel
Principal Display Panel Image of PDP
Principal Display Panel Packet Burn Jel
Principal Display Panel Burn Jel
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20171207
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.