Label: ORTHO-NESIC WITH CAPSAICIN- menthol gel
- NDC Code(s): 63347-401-01, 63347-401-02, 63347-401-03, 63347-401-04
- Packager: Blaine Labs Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
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- Active Ingredients
- Inactive Ingredients
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Before use if you are pregnant, nursing or have sensitive skin
Before use on children under the age of 2 years old
Keep Out Of The Reach Of Children
Stop Use and Contact Your Physician if conditions worsen or if symptoms persist for more than 7 days, or clear up and recur again within a few days.
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- Ortho-Nesic Label
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INGREDIENTS AND APPEARANCE
ORTHO-NESIC WITH CAPSAICIN
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63347-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.5 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.2 g in 100 g 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) TROLAMINE (UNII: 9O3K93S3TK) CAPSAICIN (UNII: S07O44R1ZM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63347-401-01 170 g in 1 TUBE; Type 0: Not a Combination Product 01/01/1995 2 NDC:63347-401-02 907 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/1995 3 NDC:63347-401-03 3629 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/1995 4 NDC:63347-401-04 85 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 01/01/1995 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/01/1995 Labeler - Blaine Labs Inc. (017314571) Registrant - Blaine Labs Inc. (017314571) Establishment Name Address ID/FEI Business Operations Blaine Labs Inc. 017314571 manufacture(63347-401)