KANGAROO CBD COOLING PAIN RELIEF- menthol, camphor gel 
SUNSET NOVELTIES, 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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72937-062-02
72937-062-04
72937-062-08
72937-062-16

Menthol 6%

Camphor 2%

Topical Analgesic.

Pain Relieving.

USES:

Aid for temporary local relief of minor aches of muscles and joints associated with simple backache, arthritis, sprains, and strains

Use only as directed. For external use only. Do not bandage tightly or use with a heating pad, pack, wrap, hot water bottle or any heating element. Keep away from children, Package not child resistant. In case of accidental ingestion, contact doctor immediately.

If prone to allergic reaction to the product consult to a doctor before using.

Avoid contact with eyes and mucous membranes, rashes wounds or damaged skin
Do not apply to wounds or damaged, broken or irritated skin

Do not apply on nose and genital area.
If rash, redness or itchiness results; discontinue use and consult a doctor.

If pregnant or breast-feeding ask a health professional before use.

DIRECTIONS:

Adults and Children over 12 years:

Apply a small amount on desired area.
Massage in circular motions until absorbed
Repeat as necessary, but no more than 3 to 4 times per day.
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Wash hands with soap and water after use.

STOP USE AND ASK A DOCTOR IF:

Conditions worsen
Redness is present
Irritation develops
Symptoms persist for more than 7 days or clear up occur again within a few days

You experience signs injury, such as pain, swelling or blistering where the product was applied.

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

Aqua, Alcohol Denat, Propylene Glycol, Salicylic Acid, Glycerin, Polysorbate 20, Carbomer, Sodium Hydroxide, Mentha Arvensis Herb Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue. 1 Powder (CI 42090), FD&C Yellow. 5 (CI 19140).

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KANGAROO CBD COOLING PAIN RELIEF 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
THYME OIL (UNII: 2UK410MY6B)  
TEA TREE OIL (UNII: VIF565UC2G)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SORBIC ACID (UNII: X045WJ989B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
Product Characteristics
ColorturquoiseScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72937-062-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product11/29/2022
2NDC:72937-062-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/29/2022
3NDC:72937-062-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/29/2022
4NDC:72937-062-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/29/2022
Labeler - SUNSET NOVELTIES, INC (067218145)

Revised: 12/2022
Document Id: eeda53d4-9b8c-525d-e053-2a95a90a078c
Set id: eea1093b-2876-5c58-e053-2995a90aca20
Version: 3
Effective Time: 20221202
 
SUNSET NOVELTIES, INC