GREEN LEAF CBD ULTRA RELIEF- menthol, camphor gel 
SURF LINE, 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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83345-602-04

Menthol 6%

Camphor 2%

Topical Analgesic.

Pain Relieving.

USES:

Aid for temporary local relief of minor pain in muscles or joints.

For external use only.

Use only as directed.
Do not bandage tightly or use with a heating pad.
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged, broken, or irritated skin.
A transient burning sensation or redness may occur upon application but generally disappears in several days.
If you experience an allergic reaction, discontinue use, and consult a doctor.

Do not expose the area treated with product to heat or direct sunlight.

Ask a health professional before use.

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

STOP USE AND ASK A DOCTOR IF:

Condition worsens.
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.

DIRECTIONS:

Adults and Children over 12 years:

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

Wash hands with soap and water after use.

Aqua, Alcohol Denat, Propylene Glycol, Polysorbate 20, Salicylic Acid, Glycerin, Carbomer, Sodium Hydroxide, Mentha Arvensis Herb Oil, Cannabidiol, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Delta-8-Tetrahydrocannabinol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Benzyl Alcohol, Sorbic Acid, FD&C Blue. 1 Powder (CI 42090), FD&C Yellow. 5 (CI 19140), Limonene.

GREEN LEAF CBD ULTRA RELIEF GEL

GREEN LEAF RELIEF GEL

GREEN LEAF CBD ULTRA RELIEF 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83345-602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2 g  in 100 g
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)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SORBIC ACID (UNII: X045WJ989B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
.DELTA.8-TETRAHYDROCANNABINOL (UNII: B49D0HH807)  
Product Characteristics
ColorturquoiseScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83345-602-04118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/17/2023
Labeler - SURF LINE, INC (091171162)

Revised: 4/2023
Document Id: f8744925-580f-d893-e053-6294a90a76e5
Set id: f8329406-9c6f-ef63-e053-6394a90a1d20
Version: 2
Effective Time: 20230403
 
SURF LINE, INC