Label: CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL- phenylephrine hydrochloride and witch hazel gel
- NDC Code(s): 69842-843-01
- Packager: CVS
- 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 November 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
- temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
- temporarily shrinks hemorrhoidal tissue
- aids in protecting irritated anorectal areas
- temporary relief of burning
-
Warnings
For external use only.
Do not use this product
- if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Ask a doctor or pharmacist before use if you are
- presently taking a prescription drug for high blood pressure or depression
-
Directions
Adults
- when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel
- apply externally to affected area up to 4 times daily or after each bowel movement
Children under 12 years old: Ask a doctor.
- Other information
- Inactive ingredients
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
CVS
Health®Compare to the active
ingredients in Preparation H®
Cooling Gel*NDC 69842-843-01
Hemorrhoidal
Cooling GelFAST COOLING RELIEF
- Clear, non-greasy formula
with soothing aloe & a
pleasant scent - Shrinks swollen
hemorrhoidal tissue - Prompt cooling relief from
painful burning & itching - Relieves external discomfort
Package Contains
One TubeNET WT 0.9 OZ (26 g)
- Clear, non-greasy formula
-
INGREDIENTS AND APPEARANCE
CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL
phenylephrine hydrochloride and witch hazel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-843 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 500 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SULISOBENZONE (UNII: 1W6L629B4K) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-843-01 1 in 1 CARTON 11/15/2006 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 final part346 01/01/2004 Labeler - CVS (062312574) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(69842-843)