Complete hemp by Complete Hemp, LLC

Drug Details [pdf]

COMPLETE HEMP- menthol, capsaicin cream
Complete Hemp, LLC

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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Active Ingredients

Menthol* 4%

Capsaicin 0.10%

Purpose

Topical analgesic

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with:

Arthritis
Backache
Strains
sprains

Warnings

For external use only. This product contains cannabinoids, including but not limited to THC, under 0.3%. If you are drug tested for any reason, please consult your testing party prior to use. If irritation occurs, discontinue use.

Flammable: Keep away from excessive heat or open flame

When using this product: Avoid contact with eyes or mucus 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 – Effects may become intensified and may re-activate during strenuous activities, perspiration or exposure to extreme heat.

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

If pregnant or breastfeeding: Ask a healthcare professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults Only: Apply generously to affected area. Gently massage in a circular motion. Use twice daily, or as needed.

For Children: Consult physician

Other information

Shake well before use. First, prime the airless bottle by pumping the top until it dispenses the product.
DO NOT puncture the self sealing membrane.
Store in a cool, dark, dry place.

Inactive ingredients

Aloe Vera*, Shea Butter*, Cetyl Alcohol (Coconut Derived), Dead Sea Magnesium Chloride, Witch Hazel*, Hemp Oil*, Lavender Oil*, Arnica, Devil’s Claw, Full Spectrum (Cannabis Sativa) [Arial Plant Parts] Oil Extract, Peppermint Oil*, Camphor, Frankincense*, Citrus Fiber, Clove Oil*, Vitamin E

*ORGANIC

Questions or Comments?:

Call us at 888-901-6150 or visit us at www.completehemp.com.

Package Label - Principal Display Panel

image description

COMPLETE HEMP
menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79551-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
WITCH HAZEL (UNII: 101I4J0U34)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
HEMP (UNII: TD1MUT01Q7)
PEPPERMINT OIL (UNII: AV092KU4JH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
FRANKINCENSE (UNII: R9XLF1R1WM)
ORANGE PEEL (UNII: TI9T76XD44)
CLOVE OIL (UNII: 578389D6D0)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 79551-002-01	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/15/2020	04/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/15/2020	04/15/2020

Labeler - Complete Hemp, LLC (117572790)

Name	Address	ID/FEI	Business Operations
Establishment
CHOICE ALL NATURAL INC D		103340792	manufacture(79551-002)

Revised: 7/2022

Document Id: e38b50ba-3392-861d-e053-2995a90a10f2

Set id: 2b081807-64af-4ba5-9669-a46a369f437f

Version: 3

Effective Time: 20220711

Trademark Results [Complete hemp]

Mark Image Registration \| Serial	Company Trademark Application Date
COMPLETE HEMP 88150803 not registered Live/Pending	Personal Health Product Development, LLC 2018-10-11