RANDEX HEMP CREAM- randex hemp cream cream 
Randex Trading Inc.

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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81852-001
RANDEX HEMP cream

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 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 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.

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

81852-001-01 30000mg in 1 box

81852-001 Directions 1

81852-001 Directions 1

81852-001 Directions 2

81852-001 label

81852-001  label

RANDEX HEMP CREAM 
randex hemp cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81852-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER4.5 mg  in 100 mg
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT) DIMETHYL SULFONE11 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL3.6 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81852-001-0130000 mg in 1 BOX; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2020
Labeler - Randex Trading Inc. (117947972)
Establishment
NameAddressID/FEIBusiness Operations
Randex Trading Inc.117947972manufacture(81852-001)

Revised: 4/2021
Document Id: c0ff9d1c-854f-6f8c-e053-2a95a90a738b
Set id: c0ff9d61-b5b3-c8b4-e053-2a95a90ab1dc
Version: 1
Effective Time: 20210427
 
Randex Trading Inc.