OLP HEMORRHOIDAL COOLING- phenylephrine hcl, witch hazel gel 
OHIO LAB PHARMA

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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ACTIVE INGREDIENT

Phenylephrine HCI, 0.25%

PURPOSE

USES

WARNINGS

For external use only

ASK A DOCTOR BEFORE USE IF YOU HAVE

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

WHEN USING THIS PRODUCT

STOP USING AND ASK YOUR DOCTOR IF

IF PREGNENT OR BREAST-FEEDING

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite

QUESTIONS

ohiolabpharma.us

PACKAGE LABEL

hemorrhoidal

COOLING RELIEF
OLP HEMORRHOIDAL COOLING GEL

OLP HEMORRHOIDAL COOLING 
phenylephrine hcl, witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70648-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE25 mg  in 1 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70648-009-011 in 1 CARTON02/01/2017
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/01/2017
Labeler - OHIO LAB PHARMA (080215854)
Registrant - OHIO LAB PHARMA (080215854)
Establishment
NameAddressID/FEIBusiness Operations
OHIO LAB PHARMA080215854manufacture(70648-009)

Revised: 11/2018
Document Id: 7b9c7b3e-3d00-9323-e053-2a91aa0a13da
Set id: 3dc07e6b-803d-1c11-e054-00144ff88e88
Version: 4
Effective Time: 20181126
 
OHIO LAB PHARMA