Label: MENTHOL, CAMPHOR gel
- NDC Code(s): 72937-600-17
- Packager: SUNSET NOVELTIES, INC
- Category: HUMAN OTC DRUG LABEL
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 December 7, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES:
- WARNINGS
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WHEN USING
WHEN USING THIS PRODUCT:
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 physician
Do not expose the area treated with product to heat or direct sunlight. - KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- STOP USE
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DIRECTIONS:
Adults and Children over 12 years:
Apply a small amount on the area to be.
Massaged in a 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, 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).
- GREEN FARM COOLING RELIEF GEL 1.7oz
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INGREDIENTS AND APPEARANCE
MENTHOL, CAMPHOR
menthol, camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72937-600 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, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)- 2 g in 100 g Inactive Ingredients Ingredient Name Strength CANNABIDIOL (UNII: 19GBJ60SN5) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CARBOMER 940 (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) SALICYLIC ACID (UNII: O414PZ4LPZ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYSORBATE 20 (UNII: 7T1F30V5YH) ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM HYDROXIDE (UNII: 55X04QC32I) THYMUS VULGARIS LEAF (UNII: GRX3499643) MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color white (Turquoise) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72937-600-17 48 g in 1 BOTTLE; Type 0: Not a Combination Product 09/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/22/2020 Labeler - SUNSET NOVELTIES, INC (067218145)