Label: GLUCOSAMINE CREAM EXTRA STRENGTH- histamine dihydrochloride cream
- NDC Code(s): 78983-101-85
- Packager: IDEAZ, 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 February 16, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- INDICATIONS & USAGE
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WARNINGS
Warnings For external use only
When using this product
- Avoid contact with eyes
- Do not bandage tightly
Do not use
- On wounds or damaged skin or if you are allergic to ingredients in this product.
Discontinue use and consult a physician if: Condition worsens or if symptoms persists for more than 7 days or clear up and occur again within a few days
- Keep out of reach of children.
- Directions
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INACTIVE INGREDIENT
Inactive ingredients Deionized water, cetearyl alcohol, emu oil, glycerine, ceteareth-20, glucosamine sulfate, dimethyl sulfone, caprylic capric triglyceride, phenoxyethanol, cetyl alcohol, methyl paraben, tocopherol acetate, butylene glycol, propylene glycol, chamomilla recutita flower extract, rosmarinus officinalis leaf extract, boswellia serrata extract, propyl paraben
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
GLUCOSAMINE CREAM EXTRA STRENGTH
histamine dihydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78983-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 0.05 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) EMU OIL (UNII: 344821WD61) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CHAMOMILE (UNII: FGL3685T2X) ROSEMARY (UNII: IJ67X351P9) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78983-101-85 85 g in 1 TUBE; Type 0: Not a Combination Product 09/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/08/2022 Labeler - IDEAZ, LLC (873184431)
