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Family Wellness by Zhejiang Jingwei Pharmaceutical Co., Ltd.

Medically reviewed on September 4, 2017

Dosage form: ointment
Ingredients: PHENYLEPHRINE HYDROCHLORIDE .25g in 100g, MINERAL OIL 14g in 100g, PETROLATUM 74.9g in 100g
Labeler: Zhejiang Jingwei Pharmaceutical Co., Ltd.
NDC Code: 55621-006

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 Facts

Inactive Ingredients - beeswax, benzoic acid, cetyl alcohol, glycerin,

laureth - 23, methylparaben, propylparaben, stearyl alcohol

Active Ingredients (in each gram)

Mineral oil 14 %

Petrolatum 74.9 %

Phenylephrine HCI  0,25 %

Purposes

--- Protectant

---Protectant

---Vasoconstrictor


Uses - Helps relieve the local itching and discomfort associated with hemorrhoids.

-Temporarily shrinks hemorrhoid tissue and relieves burning

-Temporarily provides a coating for relief of anorectal discomforts

-Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements

less painful

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 due to high blood pressure


Stop use and ask a doctor if

-bleeding occurs

-condition worsens or does not improve within 7 days.

-Introduction of the appllicator into the rectum causes additional pain

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center

right away

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 information - store at room temperature 68 - 77 F (20 - 25 C).

Questions? - 1-800-639-3803  Weekdays 9 AM to 4 PM EST

FAMILY WELLNESS  
phenylephrine hci, petrolatum, mineral oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-006
Route of AdministrationTOPICAL, RECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE.25 g  in 100 g
MINERAL OIL (MINERAL OIL) MINERAL OIL14 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM74.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
BENZOIC ACID 
CETYL ALCOHOL 
GLYCERIN 
LAURETH-23 
METHYLPARABEN 
PROPYLPARABEN 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:55621-006-011 TUBE (TUBE) in 1 BOX
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/01/2013
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
Establishment
NameAddressID/FEIOperations
Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-006)

 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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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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