Label: FAMILY WELLNESS- mineral oil, petrolatum, phenylephrine hcl ointment
- NDC Code(s): 69571-006-01, 69571-006-02
- Packager: FRONT PHARMACEUTICAL PLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 2023
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
•helps relieve the local itching and discomfort associated with hemorrhoids. Uses
•Temporarily shrinks hemorrhoid tissue and relieves burning.
•Temporarily provides a coating for relief of anorectal burning.
•Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less
painful
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WARNINGS
Warnings
For external and/or intrarectal use only
Ask a doctor before use if you have
•heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to
an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure.
Stop use and ask a doctor if
•bleeding occurs •condition worsens or does not improve within 7 days.
•introduction of the applicator into the rectum causes additional pain.
, ask a health professional before use. If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
Adults and children 12 years of age and older for topical use:
•clean the affected area, and pat or dab dry before applying ointment.
•apply to the affected area up to 4 times daily, especially after each bowel movement.
For intrarectal use:
•attach included applicator to tube.
•lubricate applicator tip and gently insert into rectum
•thoroughly clean applicator after each use, and replace cover
Children under 12 years of age: ask a doctor before use.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS
mineral oil, petrolatum, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69571-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 14 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 74.9 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) BENZOIC ACID (UNII: 8SKN0B0MIM) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LAURETH-23 (UNII: N72LMW566G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69571-006-02 1 in 1 BOX 03/30/2017 1 NDC:69571-006-01 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 03/30/2017 Labeler - FRONT PHARMACEUTICAL PLC (530897792) Establishment Name Address ID/FEI Business Operations FRONT PHARMACEUTICAL PLC 530897792 manufacture(69571-006)