Label: HEMORRHOIDAL COOLING GEL- phenylephrine and witch hazel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 24385-421-06 - Packager: Amerisource Bergen
- 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 January 4, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
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WARNINGS
For external use only.
Ask a doctor before use if you have
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- difficulty in urination due to enlargement of the prostate
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression.
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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 gel.
- When first opening the tube, puncture foil seal with top end of cap
- Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement
- SPL UNCLASSIFIED SECTION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
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PACKAGE INFORMATION
GOOD NEIGHBOR PHARMACY
NDC 24385-421-06
HEMORRHOIDAL
Cooling Gel
with Vitamin E and Aloe
Fast cooling relief from painful burning and itching
Net Wt. 0.9 oz. (26 g)
Fast cooling relief
- Clear, non-greasy formula with no unpleasant scent
- Prompt cooling relief from painful burning and itching
- Shrinks swollen hemorrhoidal tissue
- Relieves external discomfort
*Compare to active ingredients in Preparation H® Cooling Gel
FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.
Distributed By
AmerisourceBergen
Valley Forge, PA 19482-0959
Visit us at www.myGNP.com
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL COOLING GEL
phenylephrine and witch hazel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-421 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 1 g WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 50 g in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SULISOBENZONE (UNII: 1W6L629B4K) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CITRATE (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24385-421-06 1 in 1 BOX 1 26 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 08/01/2006 Labeler - Amerisource Bergen (007914906)