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Family Wellness by FRONT PHARMACEUTICAL PLC

Dosage form: cream
Ingredients: GLYCERIN 14.4g in 100g, PHENYLEPHRINE HYDROCHLORIDE .25g in 100g, PRAMOXINE HYDROCHLORIDE 1g in 100g, PETROLATUM 15g in 100g
Labeler: FRONT PHARMACEUTICAL PLC
NDC Code: 69571-004

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 ir 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. Gentlydry 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 r

in the morningor after each bowel movement.

hildren 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 hcl, pramoxine hcl, petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-004
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:69571-004-021 TUBE in 1 BOX
1NDC:69571-004-0126 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/14/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIOperations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-004)

Revised: 03/2017
 
FRONT PHARMACEUTICAL PLC

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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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