Label: RELEXO OIL- menthol, camphor oil
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Contains inactivated NDC Code(s)
NDC Code(s): 57631-116-11 - Packager: InvaTech Pharma Solutions LLC
- 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 April 19, 2017
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- Official Label (Printer Friendly)
- Relexo Massage oil Active Ingredients
- Purpose
- Uses
- Inactive Ingredients
- Direction for use
- Warnings
- Keep out of children's reach
- Other Information
- BAPS AMRUTRelexo Massage oil
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INGREDIENTS AND APPEARANCE
RELEXO OIL
menthol, camphor oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57631-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 in 1 mL CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 2.5 in 1 mL Inactive Ingredients Ingredient Name Strength MUSTARD OIL (UNII: TYY1MA9BSY) LINSEED OIL (UNII: 84XB4DV00W) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) CISSUS QUADRANGULARIS WHOLE (UNII: 3VMW64U790) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57631-116-11 1 in 1 CARTON 06/14/2017 1 50 mL in 1 BOTTLE; 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 02/28/2017 Labeler - InvaTech Pharma Solutions LLC (078602180) Registrant - InvaTech Pharma Solutions LLC (078602180) Establishment Name Address ID/FEI Business Operations InvaTech Pharma Solutions LLC 078602180 relabel(57631-116) Establishment Name Address ID/FEI Business Operations BAPS Swaminarayan Herbal Care,A Unit of Divine Energy 921183294 manufacture(57631-116) , analysis(57631-116) , pack(57631-116)