Label: PROHEMP SOOTHING MENTHOL RUB 4%- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73769-100-04, 73769-100-60 - Packager: NATURE'S FUSIONS, 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 January 31, 2022
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- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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WARNINGS
For external use only
When using this product
• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or to damaged or very sensitive skin • do not bandage tightly or use with a heating pad • Stop use and ask a doctor if • excessive redness or irritation is present • condition worsens • pain persists for more than 7 days • symptoms clear up and occur again within a few days • If pregnant or breastfeeding, ask a health professional before use. • Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROHEMP SOOTHING MENTHOL RUB 4%
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73769-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 g in 60 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) .BETA.-CARYOPHYLLENE ALCOHOL (UNII: 9Y50O7OH2E) POWDERED CELLULOSE (UNII: SMD1X3XO9M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW) FRAGRANCE 13576 (UNII: 5EM498GW35) POTASSIUM CITRATE (UNII: EE90ONI6FF) HEMP (UNII: TD1MUT01Q7) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73769-100-60 60 mL in 1 TUBE; Type 0: Not a Combination Product 01/31/2022 2 NDC:73769-100-04 113 mL in 1 JAR; Type 0: Not a Combination Product 01/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/31/2022 Labeler - NATURE'S FUSIONS, LLC (051472644) Establishment Name Address ID/FEI Business Operations NATURE'S FUSIONS, LLC 051472644 manufacture(73769-100)
