Label: PAIN RELIEVING ARTHRITIS- histamine dihydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71301-004-24 - Packager: Yash Pharmceuticals
- 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 6, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or Comments? Call 1855-314-1850
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEVING ARTHRITIS
histamine dihydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71301-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength ACRYLAMIDE (UNII: 20R035KLCI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A) EDETATE SODIUM (UNII: MP1J8420LU) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71301-004-24 144 in 1 PACKAGE 06/06/2017 1 119 g in 1 JAR; 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 05/26/2017 Labeler - Yash Pharmceuticals (871409551) Registrant - Velocity Pharma LLC (962198409) Establishment Name Address ID/FEI Business Operations Yash Pharmceuticals 871409551 manufacture(71301-004)