NDC | 70118-001-05 |
Set ID | f34aa9d9-f64c-49f3-9e8b-feb7ad1316b0 |
Category | HUMAN OTC DRUG LABEL |
Packager | GA Health and Beauty (FOSHAN) Co., Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENTS:
- PURPOSE
- USES:
-
WARNINGS:
For external use only.
- Use only as directed. Avoid contact with eyes and mucous membranes.
- Do not cover with bandage.
- Do not use on wounds or damaged skin.
- Do not use if you are allergic to Menthol.
- Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
- Or Rash, itching or excessive skin irritation occurs.
-
DIRECTIONS:
- Adults and children 12 years and over apply to affected area.
- Change patch 1 to 2 times daily.
- Children under 12 years, consult physician before use.
How to apply:
Clean and dry affected area
Cut open pouch and remove patch
Remove protective film and apply directly to area of pain
Apply to affected area not more than 3 times daily
Wash hands with soap after applying patch
Reseal pouch containing unused patches - OTHER INGREDIENTS:
- Package Label
-
INGREDIENTS AND APPEARANCE
PAINKOOLERS TOPICAL ANALGESIC PATCH
menthol and capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70118-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 1 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.05 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70118-001-05 5 in 1 POUCH 1 8 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 09/21/2015 Labeler - GA Health and Beauty (FOSHAN) Co., Ltd (544333811)