Label: MINERAL OIL- lacri-lube ointment
Contains inactivated NDC Code(s)
NDC Code(s): 21695-681-07, 21695-681-35
- Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0023-0312
- Category: HUMAN OTC DRUG LABEL
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.
Updated February 17, 2011
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- Active ingredient
- Keep Out of Reach of Children
- Other Information
- Inactive ingredients
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-681(NDC:0023-0312) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 425 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 568 mg in 1 g Inactive Ingredients Ingredient Name Strength CHLOROBUTANOL (UNII: HM4YQM8WRC) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-681-35 3.5 g in 1 TUBE 2 NDC:21695-681-07 7 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 11/30/2007 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK