Label: RANDEX HEMP CREAM cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81852-001-01 - Packager: Randex Trading Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated April 27, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
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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
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
RANDEX HEMP CREAM
randex hemp cream creamProduct 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)