Label: ROTOSXIKA LUMBAT VERTEBRA PLASTER- menthol, camphor patch
ROTOSXIKA KNEE PLASTER- menthol, camphor patch
ROTOSXIKA HERBAL PAIN PATCH- menthol, camphor patch
XINHUAZHX KNEE PLASTER- menthol, camphor patch
XINHUAZHX WORMWOOD CERVICAL PATCH- menthol, camphor patch
XINHUAZHX LUMBAT VERTEBRA PLASTER- menthol, camphor patch
ROTOSXIKA WORMWOOD CERVICAL PATCH- menthol, camphor patch
ROTOSXIKA SHOULDER PAIN PLASTER- menthol, camphor patch
XINHUAZHX SHOULDER PAIN PLASTER- menthol, camphor patch
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NDC Code(s):
83702-001-11,
83702-001-12,
83702-002-11,
83702-002-12, view more83702-003-11, 83702-003-12, 83702-004-11, 83702-004-12, 83702-005-11, 83702-005-12, 83702-006-11, 83702-006-12, 83702-007-11, 83702-007-12, 83702-008-11, 83702-008-12, 83702-009-11, 83702-009-12
- 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 September 21, 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
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WARNINGS
Precautions:
1. This product is an external product, do not take it internally;
2. This product is a health care product and does notreplace drugs and medical devices for treatment;
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.
- DOSAGE & ADMINISTRATION
- QUESTIONS
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- STATEMENT OF IDENTITY
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROTOSXIKA LUMBAT VERTEBRA PLASTER
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) SAFFLOWER (UNII: 4VBL71TY4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-007-12 12 in 1 BAG 06/01/2023 1 NDC:83702-007-11 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 ROTOSXIKA KNEE PLASTER
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) SAFFLOWER (UNII: 4VBL71TY4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-003-12 12 in 1 BAG 06/01/2023 1 NDC:83702-003-11 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 ROTOSXIKA HERBAL PAIN PATCH
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength SAFFLOWER (UNII: 4VBL71TY4Y) MYRRH (UNII: JC71GJ1F3L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-009-12 12 in 1 BAG 06/01/2023 1 NDC:83702-009-11 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 XINHUAZHX KNEE PLASTER
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) SAFFLOWER (UNII: 4VBL71TY4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-004-12 12 in 1 BAG 06/01/2023 1 NDC:83702-004-11 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 XINHUAZHX WORMWOOD CERVICAL PATCH
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) SAFFLOWER (UNII: 4VBL71TY4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-006-12 12 in 1 BAG 06/01/2023 1 NDC:83702-006-11 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 XINHUAZHX LUMBAT VERTEBRA PLASTER
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) SAFFLOWER (UNII: 4VBL71TY4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-008-12 12 in 1 BAG 06/01/2023 1 NDC:83702-008-11 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 ROTOSXIKA WORMWOOD CERVICAL PATCH
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) SAFFLOWER (UNII: 4VBL71TY4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-005-12 12 in 1 BAG 06/01/2023 1 NDC:83702-005-11 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 ROTOSXIKA SHOULDER PAIN PLASTER
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) SAFFLOWER (UNII: 4VBL71TY4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-001-12 15 in 1 BAG 06/01/2023 1 NDC:83702-001-11 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 XINHUAZHX SHOULDER PAIN PLASTER
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83702-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) SAFFLOWER (UNII: 4VBL71TY4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83702-002-12 12 in 1 BAG 06/01/2023 1 NDC:83702-002-11 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(83702-001, 83702-002, 83702-005, 83702-006, 83702-007, 83702-008, 83702-009, 83702-003, 83702-004) , label(83702-001, 83702-002, 83702-005, 83702-006, 83702-007, 83702-008, 83702-009, 83702-003, 83702-004)