HEMORROIDAL COOLING GEL- phenylephrine, witch hazel gel 
Pharmacy Value Alliance, LLC

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.

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Hemorrhoidal Cooling Gel

Drug Facts

Active Ingredient

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Active Ingredient

Witch Hazel 50%

Purpose

Astringent

Uses

Stop use and ask a doctor

If pregnant or breast feeding

Ask a doctor before use

Keep out of the reach of children

If swallowed get medical help or contact Poison Control Center right away

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

Warnings

For External Use Only

Ask doctor before use if you have

Ask doctor before use if you are presently taking a prescription drug for high blood pressure or depression.

When using this product

Other information

Store at room temperature 20°-25°C (68°-77°F)

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®

Inactive Ingredients

Aloe barbadensis gel, benzophenone-4, Acetate disodium, Hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, Vitamin E, water

Questions or Comments

Call Toll Free 1-888-296-9067

Distributed By

Premier Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087 USA

Product of PRC

Packaging

Hemorrhoidal Cooling Gel

premier value cooling gel@3x-50

HEMORROIDAL COOLING GEL 
phenylephrine, witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-054-091 in 1 BOX08/02/2018
126 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/02/2018
Labeler - Pharmacy Value Alliance, LLC (101668460)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 5/2023
Document Id: fb44e956-e4ff-501a-e053-6294a90a5d70
Set id: 7276aab8-0297-2a55-e053-2a91aa0a8d21
Version: 3
Effective Time: 20230509
 
Pharmacy Value Alliance, LLC