Label: ATOMIC BALM- methyl salicylate, capsaicin ointment
- NDC Code(s): 59316-999-21, 59316-999-96, 59316-999-97
- Packager: Performance Health, LLC
- 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 August 7, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
For external use only.
Use only as directed. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Do not apply to wounds or damaged skin. Avoid contact with the eyes. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. Consult a doctor before administering to children, including teenagers, with chicken pox or flu.
- Other information
- Inactive Ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
methyl salicylate, capsaicin ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-999 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 12.5 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-999-21 78 g in 1 TUBE; Type 0: Not a Combination Product 05/19/2017 12/31/2024 2 NDC:59316-999-96 454 g in 1 JAR; Type 0: Not a Combination Product 05/19/2017 12/31/2024 3 NDC:59316-999-97 2268 g in 1 JAR; Type 0: Not a Combination Product 05/19/2017 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/19/2017 12/31/2024 Labeler - Performance Health, LLC (794324061)