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Family Wellness by Zhejiang Jingwei Pharmaceutical Co., Ltd.

Medically reviewed on July 16, 2018

Dosage form: cream
Ingredients: GLYCERIN 14.4g in 100g, PHENYLEPHRINE HYDROCHLORIDE .25g in 100g, PRAMOXINE HYDROCHLORIDE 1g in 100g, PETROLATUM 15g in 100g
Labeler: Zhejiang Jingwei Pharmaceutical Co., Ltd.
NDC Code: 55621-012

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.

Active ingredients (in each gram)

Glycerin 14.4%

Phenylephrine HCL 0.25%

Pramoxine HCL  1%

White petrolatum  15%

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • 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 use only.

When using this product

-do not put this product into the rectum by using fingers or any mechanical device or applicator

-do not exceed recommended daily dosage unless directed by a doctor

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.

-if the symptoms being treated do not subside or if redness, irritation, swelling,

pain or other symptoms develop or increase. Some people can develop allergic

reactions to ingredients in this product.

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:

-when practical, cleanse the affected area with mild soap and warm water and

rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft

cloth before application of this product.

-apply externally to the affected area up to 4 times daily, especially at night or

in the morningor after each bowel movement.

Children under 12 years of age: consult a doctor.

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

Inactive ingredients  aloe barbadensis leaf extract,

carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,

methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,

water, xanthan gum

FAMILY WELLNESS 
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN14.4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CARBOXYMETHYLCELLULOSE SODIUM 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PARAFFIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
XANTHAN GUM 
STEARIC ACID 
POLYSORBATE 80 
Packaging
#Item CodePackage Description
1NDC:55621-012-011 TUBE in 1 BOX
126 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/14/2016
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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