说明与适用边界
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spl product data elements
Bite and Itch Diphenhydramine Hydrochloride, Pramoxine Hydrochloride STEARYL ALCOHOL MENTHOL METHYLPARABEN PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER ISOPROPYL MYRISTATE GLYCERYL STEARATE/PEG-100 STEARATE PEG-40 GLYCERYL STEARATE CETYL ALCOHOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PROPYLENE GLYCOL DIAZOLIDINYL UREA PROPYLPARABEN White to off-white
活性成分 / Active ingredient
Active ingredients Diphenhydramine HCl 2% Pramoxine HCl 1% Purposes Topical analgesic Topical analgesic
用途 / Purpose
Purposes Topical analgesic Topical analgesic
适应证 / Indications and usage
Uses Temporarily relieves pain and itching due to: scrapes sunburn minor cuts minor burns insect bites minor skin irritations poison ivy, poison oak, or poison sumac
使用说明 / Instructions for use
Directions do not use more often than directed adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor
警告 / Warnings
Warnings For external use only Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use if you have chicken pox measles When using this product do not get into eyes Stop use and ask a doctor if condition gets worse symptoms last for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on large areas of the body with any other product containing diphynhydramine, even one taken by mouth Ask a doctor before use if you have chicken pox measles When using this product do not get into eyes Stop use and ask a doctor if conditions get worse symptoms last for more than 7 days or clear up and occur again within a few days Keep out of 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 with any other product containing diphynhydramine, even one taken by mouth
咨询医生 / Ask a doctor
Ask a doctor before use if you have chicken pox measles
使用中 / When using
When using this product do not get into eyes
停用事项 / Stop use
Stop use and ask a doctor if conditions get worse symptoms last for more than 7 days or clear up and occur again within a few days
儿童安全 / Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
其他安全资料 / Other safety information
Other information store at controlled room temperature call (515) 276-1586 to report any side effects that may occur
辅料 / Inactive ingredients
Inactive ingredients cetyl alcohol, diazolidinyl urea, glyceryl stearate, isopropyl myristate, menthol, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol
用法用量原文 / Dosage and administration
Directions do not use more often than directed adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor
最近修订 / Recent changes
Added Dosage and Administration section Updated Warnings section
package label principal display panel
Bite and Itch Lotion Pramoxine HCl 1% Topical Anesthetic Diphenhydramine HCl 2% Antihistamine Pain Relieving Lotion 4 Fl Oz (118 mL) Principal Display Panel
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20241203
- 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.