Label: TOPICAL ANALGESIC- dermaline arnica menthol gel gel
- NDC Code(s): 82165-104-05
- Packager: Dermaline USA Corp
- 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 February 14, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. -
STOP USE
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Incase accidental ingestion, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
TOPICAL ANALGESIC
dermaline arnica menthol gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82165-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) EUCALYPTUS OIL (UNII: 2R04ONI662) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) AMMONIUM NONOXYNOL-9 SULFATE (UNII: 8Y8LQ8CRCC) 2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A) DMDM HYDANTOIN (UNII: BYR0546TOW) TEA TREE OIL (UNII: VIF565UC2G) CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER 940 (UNII: 4Q93RCW27E) ARNICA MONTANA (UNII: O80TY208ZW) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82165-104-05 141 g in 1 JAR; Type 0: Not a Combination Product 05/10/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/10/2021 Labeler - Dermaline USA Corp (016069241)