- DRUG FACTSActive Ingredient
- Purpose
- Keep out of reach of children
- Indications
-
Warnings
Use only as directed. For external use only. Do not use with other sprays, ointments, creams, or liniments. Do not apply to irritated skin and discontinue use if excessive skin irritation develops. Do not bandage. Do not use with heating pads or devices. When using this product avoid contact with the eyes or mucous membranes. Ask your physician before using on children under two years of age, or if you are pregnant, nursing, or have sensitive skin.
If condition worsen, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, stop use and contact your physician.
- Directions
- Other Information
- Inactive Ingredients
- Pain Relieving Gel product label
-
INGREDIENTS AND APPEARANCE
PAIN RELIEVING
menthol, camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63347-215 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.5 mg in 100 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.2 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) CARBOMER 934 (UNII: Z135WT9208) ISOPROPYL ALCOHOL (UNII: ND2M416302) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCERIN (UNII: PDC6A3C0OX) CAPSAICIN (UNII: S07O44R1ZM) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63347-215-01 88.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 04/01/2016 2 NDC:63347-215-02 177 mL in 1 TUBE; Type 0: Not a Combination Product 04/01/2016 3 NDC:63347-215-03 946.4 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2016 Labeler - Blaine Labs Inc. (017314571) Registrant - Blaine Labs Inc. (017314571) Establishment Name Address ID/FEI Business Operations Blaine Labs Inc. 017314571 manufacture(63347-215)