Label: MENTHOL, CAMPHOR cream
- NDC Code(s): 72937-310-08, 72937-310-16
- Packager: SUNSET NOVELTIES, 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 September 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES:
-
WARNINGS
Use only as directed.
For external use only.
Do not bandage tightly. Do not use with 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.
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
-
DIRECTIONS:
Adults and children over 12 years of age:
Apply a small amount on desired area.
Massage in circular motions until absorbed.
Repeat as needed but not more than 3 to 4 times a day.
Store tightly closed in a dry place at room temperature between 59°-86°(15°-30°).Wash hands with soap and water after use.
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INACTIVE INGREDIENT
Aqua, Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Parfum, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Blue #1 Powder (CI 42090).
- SUNSET PAIN RELIEF CREAM 8 oz
- SUNSET PAIN RELIEF CREAM 16 oz
-
INGREDIENTS AND APPEARANCE
MENTHOL, CAMPHOR
menthol, camphor creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72937-310 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g Inactive Ingredients Ingredient Name Strength BASIC BLUE 1 (UNII: 92N74OA24D) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TRIBUTYL CITRATE (UNII: 827D5B1B6S) PANTHENOL (UNII: WV9CM0O67Z) HYDROXYPROLINE (UNII: RMB44WO89X) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H) GLYCERETH-26 (UNII: NNE56F2N14) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) BUTETH-3 (UNII: OC116GRO69) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) TRIDECETH-6 (UNII: 3T5PCR2H0C) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z) POLYSORBATE 60 (UNII: CAL22UVI4M) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE 1000 (UNII: MCU2324216) METHYLPARABEN (UNII: A2I8C7HI9T) Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72937-310-16 456 g in 1 TUBE; Type 0: Not a Combination Product 09/19/2022 10/10/2024 2 NDC:72937-310-08 226 g in 1 TUBE; Type 0: Not a Combination Product 03/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/04/2021 Labeler - SUNSET NOVELTIES, INC (067218145) Registrant - CHEMCO CORPORATION (032495954) Establishment Name Address ID/FEI Business Operations CHEMCO CORPORATION 032495954 manufacture(72937-310)
