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Mineral Oil by Rebel Distributors Corp

Dosage form: ointment
Ingredients: MINERAL OIL 425mg in 1g, PETROLATUM 568mg in 1g
Labeler: Rebel Distributors Corp
NDC Code: 21695-681

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.

Lacri-Lube Drug Facts

Active ingredient

Mineral Oil 42.5%

White Petrolatum 56.8%

Purpose

Eye lubricant

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

For use as a protectant against further irritation or to relieve dryness or the eye.

Warnings

For external use only.

To avoid contamination, do not touch tip of container to any surface.

Replace cap after using.

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Directions

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information

Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.

Store away from heat. Protect from freezing.

Use before expiration date marked on container.

RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Chlorobutanol and lanolin alcohols.

Package/Label Principal Display Panel

MINERAL OIL 
lacri-lube ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-681(NDC:0023-0312)
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL425 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM568 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CHLOROBUTANOL 
LANOLIN ALCOHOLS 
Packaging
#Item CodePackage Description
1NDC:21695-681-353.5 g in 1 TUBE
2NDC:21695-681-077 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/30/2007
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 02/2011
 
Rebel Distributors Corp

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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