Label: AMRUT BALM- menthol, camphor ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 57631-105-08 - 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 June 23, 2017
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- Official Label (Printer Friendly)
- BAPS AMRUT BALM Active Ingredeints
- Purpose
- Uses
- Inactive Ingredients
- Directions for use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Other Information
- BAPS AMRUT BALM0.8 OZ (25 g)
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INGREDIENTS AND APPEARANCE
AMRUT BALM
menthol, camphor ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57631-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.7 g in 1 g CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 0.75 g in 1 g Inactive Ingredients Ingredient Name Strength CLOVE OIL (UNII: 578389D6D0) TURNIP-ROOTED CHERVIL OIL (UNII: XKS0X2W3DK) EUCALYPTUS OIL (UNII: 2R04ONI662) CINNAMON OIL (UNII: E5GY4I6YCZ) PEPPERMINT OIL (UNII: AV092KU4JH) NUTMEG OIL (UNII: Z1CLM48948) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57631-105-08 1 in 1 CARTON 06/14/2017 1 25 g 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 04/18/2017 Labeler - InvaTech Pharma Solutions LLC (078602180) Registrant - InvaTech Pharma Solutions LLC (078602180) Establishment Name Address ID/FEI Business Operations InvaTech Pharma Solutions LLC 078602180 label(57631-105) Establishment Name Address ID/FEI Business Operations BAPS Swaminarayan Herbal Care,A Unit of Divine Energy 921183294 manufacture(57631-105) , analysis(57631-105) , pack(57631-105)