FDA.reportPublic FDA data

Hemp Pain Lotion

Manufacturer
Sacred Enterprises, LLC | BMC 1092, Inc dba Solo Labs Inc.
Effective date
2020-03-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:04:04

Label at a glance#

ProductHemp Pain
Active ingredientMENTHOL, UNSPECIFIED FORM, Methyl Salicylate
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains for muscles and joints associated with : Simple backache arthritis strains bruises sprains

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts for Sacred Hemp Pain Lotion

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

  • Simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only Do not use

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

Stop use and ask a doctor

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets.

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

info@hempsacred.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 59 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SACRED®

revive
rejuvenate
heal

infused
pain lotion

PRINCIPAL DISPLAY PANEL - 59 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 59 ml Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73616-210-022025-01-30C16284748780-11030e365-4e18-111a-e063-dadaa90a10e2Hemp Pain Lotion
73616-210-022024-09-20C16284748780-11030e365-4e18-111a-e063-dadaa90a10e2Hemp Pain Lotion
73616-210-022024-07-30C16284748780-11030e365-4e18-111a-e063-dadaa90a10e2Hemp Pain Lotion
73616-210-022024-01-30C16284748780-11030e365-4e18-111a-e063-dadaa90a10e2Hemp Pain Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73616-210-02Hemp Pain59 mL in 1 BOTTLELOTION592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73616-210HEMP PAIN (MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE) LOTION [SACRED ENTERPRISES, LLC]2Legacy NDC, 1 package rows20200327_098a987b-ece3-421a-ae20-f849286e538a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73616-21073616-210-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
Methyl SalicylateLAV5U5022YACTIB
SHEA BUTTERK49155WL9YIACT
Benzoic Acid8SKN0B0MIMIACT
Cannabis Sativa Seed Oil69VJ1LPN1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
Cetyl Alcohol936JST6JCNIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERETH-20 COCOATE38RO881Z06IACT
Glyceryl Stearate SEFCZ5MH785IIACT
SUNFLOWER OIL3W1JG795YIIACT
Peg-20 Hydrogenated Lanolin5PP3KJ4T6SIACT
Peg-40 StearateECU18C66Q7IACT
PEG-150 STEARATE7BSG7DF10QIACT
PhenoxyethanolHIE492ZZ3TIACT
POLYACRYLAMIDE (1300000 MW)SC5Y4X78TGIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
Polysorbate 207T1F30V5YHIACT
Polysorbate 60CAL22UVI4MIACT
COCOA BUTTER512OYT1CRRIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
677d07f8-f160-486f-8308-71175e56b240098a987b-ece3-421a-ae20-f849286e538a2020-03-24WarningsExact identifier
spl id: 677d07f8-f160-486f-8308-71175e56b240
spl set id: 098a987b-ece3-421a-ae20-f849286e538a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.