HEMP PAIN- menthol, unspecified form and methyl salicylate lotion

Hemp Pain by

Drug Labeling and Warnings

Hemp Pain by is a Otc medication manufactured, distributed, or labeled by Sacred Enterprises, LLC, BMC 1092, Inc dba Solo Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts for Sacred Hemp Pain Lotion

ACTIVE INGREDIENT

Active Ingredient	Purpose
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

Directions	Adults and children 12 and older	Generously 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 age	Ask 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

INGREDIENTS AND APPEARANCE

HEMP PAIN 
menthol, unspecified form and methyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73616-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2 mg  in 100 mL
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73616-210-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	09/01/2019

Labeler - Sacred Enterprises, LLC (094283990)

Registrant - BMC 1092, Inc dba Solo Labs Inc. (078831987)

Establishment
Name	Address	ID/FEI	Business Operations
BMC 1092, Inc dba Solo Labs Inc.		078831987	MANUFACTURE(73616-210) , PACK(73616-210)