Label: MINERAL OIL LIGHT, N.F- mineral oil oil
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-185-16 - 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 August 28, 2017
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WARNINGS
Caution: For External Use Only
In case of accidental ingestion seek professional assistance or contact a Poison Control Center immediately. Avoid contact with eyes. In case of accidental eye contactl flush eyes gently with water for 15 minutes. Obtain medical attention if irritation persists. If diaper rash worsens or does not improve consult a physician
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
MINERAL OIL LIGHT, N.F
mineral oil oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-185 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 471.99 g in 472 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) 0.00472 g in 472 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-185-16 472 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/31/2015 Labeler - GERITREX LLC (112796248) Registrant - GERITREX LLC (112796248) Establishment Name Address ID/FEI Business Operations GERITREX LLC 112796248 manufacture(54162-185)