CannaSerene Hot & Cold CBD Cream

CannaSerene Hot and Cold CBD Cream by

Drug Labeling and Warnings

CannaSerene Hot and Cold CBD Cream by is a Otc medication manufactured, distributed, or labeled by BioSerene Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CANNASERENE HOT AND COLD CBD CREAM- hot and cold cream cream 
BioSerene 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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CannaSerene Hot & Cold CBD Cream

Active Ingredients

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backaches, strains, bruises, sprains, and pulled muscles.

Purpose

Topical Analgesic

Directions

• Adults and children 12 years of age and older: Massage over affected areas no more than 3 to 4 times daily. Wash hands after use.
• Children under 12 years of age: consult a doctor.

Warnings

FOR EXTERNAL USE ONLY.

Flammable. Keep away from fire or flame.

Allergy Alert. If prone to allergic reaction from aspirin or salicylates, consult doctor before use.

Do Not Use

Do not use on wounds or damaged skin or with a heating pad.

When Using This Product

• Use only as directed
• Avoid contact with eyes or mucous membranes
• Do not bandage tightly

Stop Use and Ask a Doctor

• If condition worsens
• Symptoms persist more than 7 days or clear up and occur again within a few days
• Excessive skin irritation develops.

Keep Out of Reach of Children

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

Storage and Handling

Store at controlled room temperature 20°-25°C (68°-77°F). Keep away from direct sunlight.

Inactive Ingredients

Purified Water, Menthol, Gaultheria Procumbens (Wintergreen) Leaf Oil, Fractionated Coconut Oil, Polysorbate 80, Sorbitan Stearate, Cetearyl Alcohol, Isopropyl Myristate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cannabidiol, Dimethyl Isosorbide, Oenothera Biennis (EveningPrimrose) Oil, Tocopherol Acetate (VitaminE), Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate

Labeling

CannaSerene Hot & Cold CBD Cream - For Tired Joints & Muscles

CBD 1200MG (for 100mL)

CBD Isolate 12mg/ml

• Made in USA
• Formulated By a Pharmacist
• cGMP Certified

Manufactured By: BioSerene, Inc.

4398 SW Port Way, Palm City, FL 34990 USA

CANNASERENE HOT AND COLD CBD CREAM 
hot and cold cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74787-1801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	4 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
CANNABIDIOL (UNII: 19GBJ60SN5)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74787-1801-3	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/14/2022	01/20/2025
2	NDC: 74787-1801-2	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/14/2022	01/20/2025
3	NDC: 74787-1801-0	10 mL in 1 TUBE; Type 0: Not a Combination Product	06/14/2022	01/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/14/2022	01/20/2025

Labeler - BioSerene Inc. (117473724)

Establishment
Name	Address	ID/FEI	Business Operations
BioSerene Inc.		117473724	manufacture(74787-1801)

Revised: 5/2023

Document Id: fb5acf80-7a1c-31d5-e053-6294a90abba2

34390-5

Set id: e15958d2-c32e-ee7e-e053-2995a90a741a

Version: 4

Effective Time: 20230510