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
- 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 17, 2023
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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 final part346 02/13/2018 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)
