Label: QUALI WARM- menthol, methyl salicylate patch
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Contains inactivated NDC Code(s)
NDC Code(s): 67536-883-01 - Packager: Teh Seng Pharmaceutical Mfg. Co., Ltd
- 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 October 12, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- Purpose
- Uses
- Warnings
- Stop Use
- Keep Out of Reach of Children.
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Directions
1. Clean and dry the affected areas before application.
2. Remove the protective film while applying the areas 1-2 times daily, cut into smaller size if desired. If necessary up to 3 sheets per day.
3. Use only as directed. Firmly affix with adhesive tapes or elastic bandages around joint areas to secure the patch if needed. - Storage
- Inactive Ingredients
- U.S. Sole Agent
- Drug Facts
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INGREDIENTS AND APPEARANCE
QUALI WARM
menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67536-883 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.8 g in 100 g Inactive Ingredients Ingredient Name Strength GINGER (UNII: C5529G5JPQ) GELATIN (UNII: 2G86QN327L) FRANKINCENSE (UNII: R9XLF1R1WM) MYRRH (UNII: JC71GJ1F3L) ROSIN (UNII: 88S87KL877) TURPENTINE (UNII: XJ6RUH0O4G) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67536-883-01 100 in 1 BOX 10/10/2013 1 16 g in 1 PACKET; 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 10/10/2013 Labeler - Teh Seng Pharmaceutical Mfg. Co., Ltd (656347721)