Label: BAROX S (camphor- synthetic, methyl salicylate, menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 55692-110-01 - Packager: Barox 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 September 11, 2017
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Direction
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DESCRIPTION
DESCRIPTION:
Do not use : on wounds or damage skin
Stop use and ask a doctor Stop use and ask a doctor if excessive skin irritation occurs. Ask a doctor before use if you have redness over the affected area
Other Information : Store in a cool dry place with lid closed tightly
Question Contact : jhs3840@naver.com
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BAROX S
camphor (synthetic), methyl salicylate, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55692-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 7.08 g in 120 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 5.52 g in 120 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.96 g in 120 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) AVOCADO OIL (UNII: 6VNO72PFC1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55692-110-01 120 g in 1 CARTON; Type 0: Not a Combination Product 03/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2014 Labeler - Barox Co., Ltd. (688380051) Registrant - Barox Co., Ltd. (688380051) Establishment Name Address ID/FEI Business Operations Gdkcosmetics Co., Ltd. 557821946 manufacture(55692-110)