Label: FAMILY WELLNESS- glycerin, phenylephrine hcl, pramoxine hcl, petrolatum cream
- NDC Code(s): 69571-004-01, 69571-004-02
- Packager: FRONT PHARMACEUTICAL PLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated February 17, 2020
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- ACTIVE INGREDIENT
INDICATIONS & USAGE
- 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
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
DOSAGE & ADMINISTRATION
-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.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
glycerin, phenylephrine hcl, pramoxine hcl, petrolatum cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69571-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 14.4 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 15 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PARAFFIN (UNII: I9O0E3H2ZE) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) STEARIC ACID (UNII: 4ELV7Z65AP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69571-004-02 1 in 1 BOX 03/14/2017 1 NDC:69571-004-01 26 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 final part346 03/14/2017 Labeler - FRONT PHARMACEUTICAL PLC (530897792) Establishment Name Address ID/FEI Business Operations FRONT PHARMACEUTICAL PLC 530897792 manufacture(69571-004)