FAMILY WELLNESS HEMORRHOID- glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream

Family Wellness HEMORRHOID by

Drug Labeling and Warnings

Family Wellness HEMORRHOID by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR (Family Wellness). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active ingredient 

Glycerin 14.4%

Phenylephrine HCl 0.25%         

Pramoxine HCl 1%                   

White petrolatum 15%             

Pupose 

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

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

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 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 

store at controlled room temperature 68-77°F (20-25°C)

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

Principal Display Panel 

FamilyWellness       NDC: 55319-981-25Maxium Strength Hemmorodial Cream NET WT 0.9oz (26g)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS HEMORRHOID 
glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream

Product 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)