HEMP PAIN BALM SACRED PAIN BALM- .alpha.,.alpha.-dibromo-d-camphor and menthol, unspecified form ointment

Hemp Pain Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredient	Purpose
Camphor 1 %	Topical Analgesic
Menthol 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

• 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

Beeswax, cannabis sativa seed oil, chamomilla recutita (matricaria) flower extract, helianthus annuus (sunflower) seed oil, lavandula angustifolia (lavender) oil, limnanthes alba (meadowfoam) seed oil, mentha piperita (peppermint) oil, olea europaea (olive) fruit oil, prunus amygdalus dulcis (sweet almond) oil, ricinus communis (castor) seed oil, tocopheryl acetate.

QUESTIONS

info@hempsacred.com

SPL UNCLASSIFIED SECTION

Distributed by SACRED®
1916 Raymond Dr. Northbrook, IL 60062

PRINCIPAL DISPLAY PANEL - 57 g Jar Label

SACRED®

infused
pain balm

2oz (57g)

INGREDIENTS AND APPEARANCE

HEMP PAIN BALM   SACRED PAIN BALM
.alpha.,.alpha.-dibromo-d-camphor and menthol, unspecified form ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73616-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O) (.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR - UNII:F89Z8SAG3O)	.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR	1 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
Cannabis Sativa Seed Oil (UNII: 69VJ1LPN1S)
Matricaria Chamomilla Root (UNII: BTG5H50X7F)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
Mentha piperita (UNII: 79M2M2UDA9)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
ALMOND OIL (UNII: 66YXD4DKO9)
CASTOR OIL (UNII: D5340Y2I9G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73616-208-02	57 g in 1 JAR; 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 Laboratories Inc (078831987)

Establishment
Name	Address	ID/FEI	Business Operations
BMC 1092, Inc dba Solo Laboratories Inc		078831987	MANUFACTURE(73616-208) , PACK(73616-208)