- Active Ingredient
- Uses
- Do Not Use
- Stop use and ask a physicinan if:
- Directions
- Storage
- Inactive Ingredient
- Warnings For External Use Only:
- Distributed By
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAINZONE LIGHT
painzone light creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70338-651 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 35 mg in 1 g Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER 940 (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) LAURETH-4 (UNII: 6HQ855798J) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461) ALCOHOL (UNII: 3K9958V90M) PINEAPPLE (UNII: 2A88ZO081O) WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70338-651-01 113 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2019 Labeler - MEDZONE PRODUCTS LLC (080083739) Establishment Name Address ID/FEI Business Operations Dhaliwal Laboratories LLC 016754201 manufacture(70338-651)