RANDEX HEMP cream by Randex Trading Inc. RANDEX HEMP CREAM cream

RANDEX HEMP cream by

Drug Labeling and Warnings

RANDEX HEMP cream by is a Otc medication manufactured, distributed, or labeled by Randex Trading Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

MSM 11% ............................................................. Cooling Pain Relief
Arnica montana 4.5% ...................................................... Treat Arthritis
Menthol 3.6% ............................................................ Relieves muscle

Purpose

Active Ingredients Purpose
MSM 11% ............................................................. Cooling Pain Relief
Arnica montana 4.5% ...................................................... Treat Arthritis
Menthol 3.6% ............................................................ Relieves muscle

Use

Flammab Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Warnings

For external use only.

Flammab Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

If pregnant or breast-feeding: Ask a health professional before use.

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Do not use

● Do not use with other ointments, creams, sprays or liniments
●Do not use with heating pad or device.

WHEN USING

When using this product:
● Avoid contact with the eyes or mucous membranes
● Do not apply to wounds or damaged skin
● Do not use with other ointments, creams, sprays or liniments
● Do not apply to irritated skin or if excessive irritation develops
● Do not bandage
● Wash hands after use with cool water
● Do not use with heating pad or device.

STOP USE

Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

If pregnant or breast-feeding: Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and older:
● apply generously to affected area
● massage into painful area until thoroughly absorbed into skin
● repeat as necessary ,but no more than 4 times daily .
Children 12 years or younger: Consult physician.

Other information

Store at room temperature with the cap closed
Notice: because this product contains natural nutrients,color may vary.

Inactive ingredients

Argan oil, Jojoba oil, Emu oil, Hempseed oil, Turmeric, Aloe vera, Squalane , Beeswax, Rosmarinus Officinalis leaf oil, Benzyl alcohol, Capsaicin, Carbomer940, Purified Water.

Package Label - Principal Display Panel

81852-001-01 30000mg in 1 box

81852-001 Directions 1

81852-001 label

INGREDIENTS AND APPEARANCE

RANDEX HEMP CREAM 
randex hemp cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81852-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	4.5 mg  in 100 mg
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT)	DIMETHYL SULFONE	11 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL	3.6 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CAPSAICIN (UNII: S07O44R1ZM)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
TURMERIC (UNII: 856YO1Z64F)
ARGAN OIL (UNII: 4V59G5UW9X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EMU OIL (UNII: 344821WD61)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ROSEMARY OIL (UNII: 8LGU7VM393)
BENZYL ALCOHOL (UNII: LKG8494WBH)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81852-001-01	30000 mg in 1 BOX; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2020

Labeler - Randex Trading Inc. (117947972)

Establishment
Name	Address	ID/FEI	Business Operations
Randex Trading Inc.		117947972	manufacture(81852-001)