Label: REMATEX- rematex pain relievingcream cream
- NDC Code(s): 69379-041-01
- Packager: Home Aide Diagnostics, 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 June 30, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
-
DOSAGE & ADMINISTRATION
DIRECTIONS
- Clean and dry affected area
- Remove patch from backing and apply to affected area
- Use only one patch at a time and maximum of four patches daily
- Leave patch on affected area for up to 8-hours
- Do not use patches for longer than 5 consecutive days unless directed by a physician.
- Store below 25 °C (77 °F). Avoid direct sunlight.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
REMATEX
rematex pain relievingcream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69379-041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69379-041-01 120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2015 Labeler - Home Aide Diagnostics, Inc. (783518983) Registrant - Zhejiang Bangli Medical Products Co. Ltd (421295875) Establishment Name Address ID/FEI Business Operations Zhejiang Bangli Medical Products Co. Ltd 421295875 manufacture(69379-041)