Otc - Active Ingredient
Active ingredient:
Docylamine succinate 5g/100g, Diphenhydramine hydrochloride 3g/100g, Camphor 3g/100g, Chamomile 3g/100g
Rotosxika Sleep Aid Patch
FDA Label NDC 83702-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puning Xinhua Trade Co., Ltd. for the product Rotosxika Sleep Aid Patch (NDC 83702-020). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - questions, inactive ingredient, statement of identity, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Helps sleep
Indications & Usage
Use to:
Temporary relief of occasional mild pain, accompanying insomnia, nighttime sleep aid
Dosage & Administration
Directions:
External use. Clean the area of use, remove the release paper, and apply it to the Yongquan acupoint on the foot of the human body or the Shenque acupoint on the navel of the human body.
Warnings
Precautions
1.This product is an external product, do not take it internally;
2.This product is a health care product and does not replace drugs and medical devices fortreatment;
3.Pregnant women, infants, breastfeeding, and those allergic to this product are prohibited;
4.Do not use skin allergies, skin damage, skin diseases and other symptoms;
5.If the skin appears red, itchy and other abnormal conditions during use, please suspend use
Otc - Questions
Questions or comments? +8617846992567
Inactive Ingredient
Inactive Ingredients: Spice,Glycerol,Sorbitol,Sucralose
Statement Of Identity
Other information:
Sealed packaging,please keep in a cool and dark place.
Produced by:
Nanyang Jingzhilan Biotechnology Co., Ltd
No.6,Road2,Longsheng Industrial Park,Wangcun Township, Wolong District, Nanyang City
OEM Company: Puning Xinhua Trade Co., Ltd
Made in China
Otc - Keep Out Of Reach Of Children
Same as WARNINGS SECTION
Package Label.Principal Display Panel
Label
* Please review the disclaimer below.
