Label: MINERAL OIL oil
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-0360-16 - Packager: Walgreens
- 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 November 18, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- PURPOSE
- Uses
- Warnings
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if you have
- If pregnant or breast feeding,
- Keep this and all drugs out of the reach of children
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Directions
do not take with meals
take only at bedtime
may be taken as a single daily dose or in divided doses
age dose
adults and children over 12 years 1 to 3 tablespoons (15 to 45 ml)
maximum3 tablespoons (45mL) in 24 hours
children 6 years to under 12 years 1 to 3 tablespoons (15 to 45 ml)
maximum3 tablespoons (45mL) in 24 hours
children under 6 years do not use, consult a doctor
- Other Information
- Inactive Ingredient
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MINERAL OIL
mineral oil oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0360 Route of Administration TOPICAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 15 mL in 15 mL Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0360-16 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/02/2009 Labeler - Walgreens (008965063) Registrant - Aaron Industries Inc. (030119387) Establishment Name Address ID/FEI Business Operations Aaron Industries Inc. 030119387 manufacture, analysis