Label: HEMP PAIN- menthol, unspecified form and methyl salicylate lotion

  • NDC Code(s): 73616-210-02
  • Packager: Sacred Enterprises, 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 March 24, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts for Sacred Hemp Pain Lotion

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Menthol 2%Topical Analgesic
    Methyl Salicylate 6%Topical Analgesic
  • Uses

    For the temporary relief of minor aches and pains for muscles and joints associated with :

    • Simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only Do not use

    • if seal is missing or broken
    • otherwise than as directed

    Stop use and ask a doctor

    • if pain persists for more than 3 days
    • condition worsens
    • New symptoms occur
    • if redness irritation or swelling are present

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children and pets.

    If swallowed , get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DirectionsAdults and children 12 and olderGenerously apply 2-3 times daily or more often if needed on and around the affected area. Massage in until absorbed, reapply before bedtime and in the morning. Use before and after sports work outs and competitions.
    Children under 12 years of ageAsk a doctor.
  • Inactive ingredients

    Benzoic acid, Butyrospermum parkii ( shea) butter, Cannabis sativa seed oil, Ceteareth-20,cetearyl alcohol, Cetyl alcohol, Cocos Nucifera ( coconut) oil, Ethylhexylglycerin, Glycereth 2 cocoate, Glyceryl stearate SE, Helianthus annuus ( sunflower) seed oil , PEG -150 stearate, PEG-20 hydrogenated lanolin, PEG-40 stearate, Phenoxyethanol polyacrulate-13, Polyisobutene, Polysorbate 20, Polysorbate 60, Theobroma cacao ( cocoa) seed butter, Water.

  • QUESTIONS

    info@hempsacred.com

  • SPL UNCLASSIFIED SECTION

    Distributed by SACRED®
    1916 Raymond Drive,
    Northbrook, IL 60062

  • PRINCIPAL DISPLAY PANEL - 59 ml Bottle Label

    SACRED®

    revive
    rejuvenate
    heal

    infused
    pain lotion

    PRINCIPAL DISPLAY PANEL - 59 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    HEMP PAIN 
    menthol, unspecified form and methyl salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73616-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2 mg  in 100 mL
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate6 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Cannabis Sativa Seed Oil (UNII: 69VJ1LPN1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERETH-20 COCOATE (UNII: 38RO881Z06)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Peg-20 Hydrogenated Lanolin (UNII: 5PP3KJ4T6S)  
    Peg-40 Stearate (UNII: ECU18C66Q7)  
    PEG-150 STEARATE (UNII: 7BSG7DF10Q)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73616-210-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34809/01/2019
    Labeler - Sacred Enterprises, LLC (094283990)
    Registrant - BMC 1092, Inc dba Solo Labs Inc. (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc dba Solo Labs Inc.078831987MANUFACTURE(73616-210) , PACK(73616-210)
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