NDC | 59779-403-60, 59779-403-61 |
Set ID | 37b1e849-3079-4f8e-b712-9520a1e0dd89 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Glycerin 14.4%.................................................Protectant
Petrolatum 15.0%.............................................Protectant
Phenylephrine Hydrochloride.............................Vasoconstrictor
Pramoxine Hydrochloride..................................Local anesthetic -
PURPOSE
Active ingredients Purpose
Glycerin 14.4%.................................................Protectant
Petrolatum 15.0%.............................................Protectant
Phenylephrine Hydrochloride.............................Vasoconstrictor
Pramoxine Hydrochloride..................................Local anesthetic
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 - KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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
Other information- store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)
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WARNINGS
Warnings
For external use only.
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 or depression
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away -
DOSAGE & ADMINISTRATION
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 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 cap partway into the anus.
- thoroughly cleanse dispensing cap after each use and replace cover
- children under 12 years of age: ask a doctor -
INACTIVE INGREDIENT
Inactive Ingredients aloe barbadensis leaf juice, butylated hydroxyanisole,
cellulose gum, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate SE,
laureth-23, methylparaben, mineral oil, penthenol, propylene glycol, propyl gallate,
propylparaben, purified water, sodium benzoate, steareth-2, steareth-20,
stearyl alcohol, tocopheryl acetate, xanthan gum - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS HEMORRHOIDAL
pramoxine hydrochloride, glycerin, phenylephrine hydrochloride and petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-403 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 144 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 150 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) LAURETH-23 (UNII: N72LMW566G) MINERAL OIL (UNII: T5L8T28FGP) PANTHENOL (UNII: WV9CM0O67Z) PROPYL GALLATE (UNII: 8D4SNN7V92) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARETH-2 (UNII: V56DFE46J5) STEARETH-20 (UNII: L0Q8IK9E08) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) XANTHAN GUM (UNII: TTV12P4NEE) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) EDETATE DISODIUM (UNII: 7FLD91C86K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-403-60 1 in 1 CARTON 1 28 g in 1 TUBE, WITH APPLICATOR 2 NDC:59779-403-61 1 in 1 CARTON 2 51 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/15/2010 Labeler - CVS Pharmacy (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture