HEMP PAIN- menthol, unspecified form and methyl salicylate lotion 
Sacred Enterprises, LLC

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.

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Hemp Pain Lotion

Drug Facts for Sacred Hemp Pain Lotion

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 :

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.

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

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
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)

Revised: 3/2020
Document Id: 677d07f8-f160-486f-8308-71175e56b240
Set id: 098a987b-ece3-421a-ae20-f849286e538a
Version: 2
Effective Time: 20200324
 
Sacred Enterprises, LLC