Label: CICLOFERON- benzalkonium chloride and lidocaine hydrochloride gel
- NDC Code(s): 59208-002-04, 59208-002-05
- Packager: Laboratorios Liomont, S.A. de C.V.
- 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 May 16, 2019
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
CICLOFERON
benzalkonium chloride and lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59208-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 g Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59208-002-04 1 in 1 CARTON 05/01/2019 1 4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:59208-002-05 1 in 1 CONTAINER 05/01/2019 2 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/01/2019 Labeler - Laboratorios Liomont, S.A. de C.V. (810347807) Establishment Name Address ID/FEI Business Operations Laboratorios Liomont, S.A. de C.V. 810347807 manufacture(59208-002)