Label: GREEN LEAF CBD ULTRA RELIEF- menthol, camphor gel
- NDC Code(s): 83345-602-04
- Packager: SURF LINE, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 3, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES:
- WARNINGS
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WHEN USING
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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- STOP USE AND ASK A DOCTOR IF:
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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.
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INACTIVE INGREDIENT
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
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INGREDIENTS AND APPEARANCE
GREEN LEAF CBD ULTRA RELIEF
menthol, camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83345-602 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 6 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 2 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color turquoise Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83345-602-04 118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/17/2023 Labeler - SURF LINE, INC (091171162)