ROTOSXIKA SLEEP AID PATCH- docylamine succinate, diphenhydramine hydrochloride, chamomile, camphor patch

Rotosxika Sleep Aid Patch by

Drug Labeling and Warnings

Rotosxika Sleep Aid Patch by is a Otc medication manufactured, distributed, or labeled by Puning Xinhua Trade Co., Ltd., Nanyang Jingzhilan Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient:

Docylamine succinate 5g/100g, Diphenhydramine hydrochloride 3g/100g, Camphor 3g/100g, Chamomile 3g/100g

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

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

KEEP OUT OF REACH OF CHILDREN

Same as WARNINGS SECTION

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

ROTOSXIKA SLEEP AID PATCH 
docylamine succinate, diphenhydramine hydrochloride, chamomile, camphor patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83702-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	3 g  in 100 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	3 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3 g  in 100 g
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
ALLSPICE (UNII: I5GZG55B36)
GLYCEROL FORMAL (UNII: 3L7GR2604E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83702-020-12	7 in 1 BAG	06/01/2023
1	NDC: 83702-020-11	2.1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2023

Labeler - Puning Xinhua Trade Co., Ltd. (632673277)

Registrant - Nanyang Jingzhilan Biotechnology Co., Ltd. (724044399)

Establishment
Name	Address	ID/FEI	Business Operations
Nanyang Jingzhilan Biotechnology Co., Ltd.		724044399	manufacture(83702-020) , label(83702-020)