Label: FAMILY WELLNESS HEMORRHOID- glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream
- NDC Code(s): 55319-981-25
- Packager: FAMILY DOLLAR (Family Wellness)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Pupose
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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
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Warnings
For external use only
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before useif you are presently taking a prescription drug for high blood pressure or depression.
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days
- an allergic reaction develops
- the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
If pregnant or breast-feeding,ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
- when first opening the tube, puncture foil seal with top end of cap
- apply externally or in the lower portion of the anal canal only
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
- thoroughly cleanse dispensing cap after each use and replace cover
- children under 12 years of age: ask a doctor
- Other Information
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Inactive Ingredients:
Aloe Vera Leaf, Cellulose Gum, Cetyl Alcohol, Citric Acid, Disodium EDTA, Glyceryl Stearate SE, Laureth-23, Methylparaben, Mineral Oil, Panthenol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Steareth-2, Steareth-21, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Water (purified), Xanthan Gum
- Question?1-00-814-8020
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS HEMORRHOID
glycerin, petrolatum, phenylephrine hcl, pramoxine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-981 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 144 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 2.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 150 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM BENZOATE (UNII: OJ245FE5EU) TOCOPHEROL (UNII: R0ZB2556P8) METHYLPARABEN (UNII: A2I8C7HI9T) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LAURETH-23 (UNII: N72LMW566G) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-981-25 1 in 1 CARTON 10/02/2023 1 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 Drug M015 10/02/2023 Labeler - FAMILY DOLLAR (Family Wellness) (024472631)