MINERAL OIL- mineral oil oil 
Care One (American Sales Company)

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.

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Drug Facts

Active Ingredient

Mineral Oil 100%

Purpose

Lubricant laxative

Uses

Warnings

Do not use

  • in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for longer than 1 week

Ask a doctor before use if you have

  • abdominal pain, nausea or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

  • do not take with meals
  • take only at bedtime

Stop use and ask a doctor if you have

rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast feeding,

ask a health professional before use

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

Directions

Other Information

Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

MINERAL OIL

Lubricant Laxative     

ODORLESS, TASTELESS, COLORLESS

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949 •©2016 S&S Brands,LLC

Questions or comment?

Call 1-877-753-3935 Monday-Friday 9am-5pm EST

Package Label

Mineral oil 100%

CareOne Mineral Oil

 

MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-334
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-334-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/201602/28/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/30/201602/28/2025
Labeler - Care One (American Sales Company) (809183973)

Revised: 11/2022
Document Id: b6ca4adf-b868-4822-8e37-3f532726aa09
Set id: 33ebb291-74a2-40a8-aada-6c422e63e757
Version: 3
Effective Time: 20221121
 
Care One (American Sales Company)