Label: PERFORM - menthol spray
- NDC Code(s): 59316-109-27, 59316-109-29
- Packager: Performance Health LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
Menthol USP 10.4%Close
Cooling Pain ReliefClose
Soothing On-The-Go temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort, arthritis.Close
For external use only.
Ask a Doctor Before Using This Product If You: Have sensitive skin, are pregnant or are breastfeeding.
When Using This Product:
- Avoid contact with eyes or mucous membranes
- Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops
- Do not bandage or use with a heating pad or device, ointments, creams, sprays, liniments
Stop Use and Ask a Doctor If:
Condition worsens, symptoms persist more than 7 days, or clear up and reoccur.
Keep Out of Reach of Children:
If ingested, get medical help. Contact Poison Control Center immediately.
- Adults / Children 12 years and older: Apply on to affected area up to 4 times daily
- Children under 12 years of age: Consult a physician
- Other Information:
Store in a cool, dry place out of direct sunlight.Close
- Inactive Ingredients:
Arnica Extract, Eucalyptus Oil, Ilex Paraguariensis Extract, Lavender Oil, Lime Oil, Natural Camphor USP, Nutmeg Oil, Orange Oil, Peppermint Oil, Pine Oil, Polysorbate 20, SD Alcohol 39-C, Thyme Oil, Purified Water, White Tea ExtractClose
- Questions or Comments?
- Representative Labeling
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59316-109 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 104 mg in 1 mL Inactive Ingredients Ingredient Name Strength ARNICA MONTANA EUCALYPTUS OIL ILEX PARAGUARIENSIS LEAF LAVENDER OIL LIME OIL CAMPHOR (SYNTHETIC) NUTMEG OIL ORANGE OIL PEPPERMINT OIL WHITE PINE OIL POLYSORBATE 20 THYME OIL WATER Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-109-27 10 in 1 BOX 1 1 mL in 1 PATCH 2 NDC:59316-109-29 118 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/10/2013 Labeler - Performance Health LLC (794324061) Establishment Name Address ID/FEI Business Operations Span Packaging Services LLC 557434805 manufacture(59316-109) Establishment Name Address ID/FEI Business Operations Tapemark Company 006154595 manufacture(59316-109)