Label: HEMORROIDAL COOLING GEL- phenylephrine, witch hazel gel
- NDC Code(s): 69396-032-18
- Packager: Trifecta Pharmaceuticals Usa Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- Drug Facts
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses
- Stop use and ask a doctor
- If pregnant or breast feeding
- Keep out of the reach of children
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Directions
Children under 12 years of age; ask a doctor before use
Adults: when practical, clean 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
- when first opening tube, remove foil seal
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
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Warnings
For External Use Only
Ask doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty urinating due to an enlarged prostate gland
Ask doctor 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 the rectum by using fingers or any mechanical device or applicator
- Other information
- Inactive Ingredients
- Questions or Comments
- Distributed By
- Packaging
-
INGREDIENTS AND APPEARANCE
HEMORROIDAL COOLING GEL
phenylephrine, witch hazel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.5 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) METHYLPARABEN (UNII: A2I8C7HI9T) SULISOBENZONE (UNII: 1W6L629B4K) EDETATE DISODIUM (UNII: 7FLD91C86K) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PROPYLPARABEN (UNII: Z8IX2SC1OH) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-032-18 1 in 1 BOX 02/13/2018 1 56 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 02/13/2018 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)