Label: ROTOSXIKA VENTILATION HEALTH PATCH- doxylamine succinate, diphenhydramine hydrochloride, camphor, chamomile patch
- NDC Code(s): 83702-021-11, 83702-021-12
- Packager: Puning Xinhua Trade Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
Directions: Wipe the application area clean with warm water and let it dry.Take out the product, tear off the isolation film, and apply it to Tiantu acupoint Zhongwan acupoint and other acupoints.Multiple acupoints can be used alternately or applied simultaneously, with a duration of 6-8 hours. It is recommended to apply at night.
-
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
- INACTIVE INGREDIENT
- STATEMENT OF IDENTITY
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROTOSXIKA VENTILATION HEALTH PATCH
doxylamine succinate, diphenhydramine hydrochloride, camphor, chamomile patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 3 g in 100 g DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 5 g in 100 g CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 3 g in 100 g CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) ALLSPICE (UNII: I5GZG55B36) GLYCEROL FORMAL (UNII: 3L7GR2604E) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-021-12 6 in 1 BAG 06/01/2023 1 NDC:83702-021-11 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(83702-021) , label(83702-021)