Label: HEMORRHOIDAL ANESTHETIC- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream
- NDC Code(s): 71003-001-01
- Packager: Purity Products
- 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.
Drug Label Information
Updated October 25, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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 and relieves burning
- 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 urinating due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are 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
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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 soft cloth before applying the cream
- When first opening the tube, remove the foil seal
- 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 the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, then gently insert the dispensing cap partway into the anus.
- Thoroughly cleanse the dispensing cap after each use, and replace the cover
- Children under 12 years: ask a doctor
- Other Information
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Inactive Ingredient
Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum
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- PRINCIPAL DISPLAY PANEL - 25.5 G Tube Carton
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL ANESTHETIC
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71003-001 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 HYDROCHLORIDE 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-23 (UNII: N72LMW566G) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PANTHENOL (UNII: WV9CM0O67Z) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) STEARETH-2 (UNII: V56DFE46J5) STEARETH-20 (UNII: L0Q8IK9E08) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71003-001-01 1 in 1 CARTON 10/20/2016 1 25 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 10/20/2016 Labeler - Purity Products (807859509) Establishment Name Address ID/FEI Business Operations Natureplex 062808196 MANUFACTURE(71003-001)
