Label: CALADROX- menthol, zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-229-04 - Packager: Geritrex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 29, 2015
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INGREDIENTS AND APPEARANCE
CALADROX
menthol, zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-229 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.44 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) PHENOL (UNII: 339NCG44TV) SODIUM BICARBONATE (UNII: 8MDF5V39QO) THYMOL (UNII: 3J50XA376E) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DMDM HYDANTOIN (UNII: BYR0546TOW) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-229-04 113 g in 1 TUBE; Type 0: Not a Combination Product 09/29/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/29/2015 Labeler - Geritrex LLC (112796248) Registrant - Geritrex LLC (112796248) Establishment Name Address ID/FEI Business Operations Geritrex LLC 112796248 manufacture(54162-229)