Label: SOLSTICE CAPSAICIN PATCH HOT- capsaicin patch
- NDC Code(s): 55614-410-01, 55614-410-03
- Packager: MADISON ONE ACME INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 3, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
-
WHEN USING
When using this product
avoid contact with the eyes or mucous membranes
do not bandage tightly
do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch -
STOP USE
Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive irritation of the skin develops
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
when using for pain of arthritis:
pain persists for more than 10 days
redness is present
in conditions affecting children under 12 years of age - ADVERSE REACTIONS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
adults and children 12 years of age and older:
clean and dry affected area
remove the protective film from the patch
apply patch to affected area not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application
wet patch with warm water before removing from the skin
children under 12 years of age: consult your physician - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SOLSTICE CAPSAICIN PATCH HOT
capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55614-410 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) LIQUID PETROLEUM (UNII: 6ZAE7X688J) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55614-410-01 1 in 1 POUCH 09/18/2019 1 9 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:55614-410-03 3 in 1 POUCH 09/18/2019 2 9 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 OTC monograph not final part348 09/18/2019 Labeler - MADISON ONE ACME INC (096196758) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co., Ltd., 529128763 manufacture(55614-410)
