Label: POMG PAIN RELIEF ROLLER- lidocaine hydrochloride, menthol gel
- NDC Code(s): 84615-004-02, 84615-004-03
- Packager: POMG LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 27, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
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Warnings
For external use only
Do not use
• If you are allergic to any ingredients in this product
• On open sores and wounds
• In large quantities
When using this product
• Use only as directed
• Do not bandage tightly
• Avoid contact with eyes and other mucous membranes
• Do not expose the area to external heat or direct sunlight
Stop use and consult a doctor if
• Conditions worsen or symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days
• Redness is present or excessive skin irritation occurs
• You experience severe burning pain, swelling, or blistering where product was applied
• Allergic reaction occurs
- Directions
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POMG PAIN RELIEF ROLLER
lidocaine hydrochloride, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84615-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg in 1 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A) PAPRIKA (UNII: X72Z47861V) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84615-004-03 90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 08/14/2024 2 NDC:84615-004-02 1 in 1 CARTON 08/14/2024 2 59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 08/14/2024 Labeler - POMG LLC (119126509) Establishment Name Address ID/FEI Business Operations POMG LLC 119126509 manufacture(84615-004)