SIMPLY VITAL PAIN RELIEF HEMP- menthol cream
ALPHA PLANTS 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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SIMPLY VITAL PAIN RELIEF HEMP CREAM

Drug Facts

Active Ingredient

Menthol 8.00%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains

Warnings:

For external use only.

Do not use:

on damaged or brosken skin.

When using this product

Avoid contact with eyes.
Do not bandage tightly.

Stop use and ask a doctor if

Rash or irritation develops and lasts.
Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding,

ask a health professional before use.

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor.

Other information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine.

Questions?:

+1 (205) 624-9177

Package Labeling:

Label

SIMPLY VITAL PAIN RELIEF HEMP
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82460-345
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	80 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82460-345-00	120 mL in 1 JAR; Type 0: Not a Combination Product	08/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/01/2022

Labeler - ALPHA PLANTS INC (118246522)

Revised: 7/2022

Document Id: e44cc2f1-d52a-ba0c-e053-2a95a90a7205

Set id: c14f4c06-cfe5-497e-9f9e-b2ba442e61bb

Version: 1

Effective Time: 20220721

ALPHA PLANTS INC