PREPARATION H MAXIMUM STRENGTH- glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream 
GlaxoSmithKline Consumer Healthcare Holdings (US) 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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PREPARATION H®

Drug Facts

Active ingredientsPurposes

Glycerin 14.4%

Protectant

Phenylephrine HCl 0.25%

Vasoconstrictor

Pramoxine HCl 1%

Local anesthetic

White petrolatum 15%

Protectant

Uses

for temporary relief of pain, soreness and burning
helps relieve the local itching and discomfort associated with hemorrhoids
temporarily shrinks hemorrhoidal tissue
temporarily provides a coating for relief of anorectal discomforts
temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For external use only

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland

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

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

Stop use and ask a doctor if

bleeding occurs
condition worsens or does not improve within 7 days
an allergic reaction develops
the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

If pregnant 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

Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
when first opening the tube, puncture foil seal with top end of cap
apply externally or in the lower portion of the anal canal only
apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
thoroughly cleanse dispensing cap after each use and replace cover
children under 12 years of age: ask a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

PREPARATION H®

HEMORRHOIDAL
CREAM

Multi-Symptom
Pain Relief

WITH
ALOE

New Look,
SAME SIZE!

Soothing Pain Relief from Burning,
Itching, & Discomfort
Shrinks Swollen Hemorrhoidal Tissue
Protects Irritated Tissue
Relieves External Discomfort
Proprietary Blend with Vitamin E
and Aloe

1 TUBE | NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton

PREPARATION H®
HEMORRHOIDAL CREAM

Maximum Strength Pain Relief

Smooth Cream
Formula with Aloe

1.
Rapid, Soothing Pain Relief from Painful
Burning, Itching and Discomfort
2.
Shrinks Swollen Hemorrhoidal Tissue
3.
Protects Irritated Tissue
4.
Relieves External Discomfort

NET WT. 1.8 OZ (51 g)

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98

PREPARATION H®

HEMORRHOIDAL
CREAM

Multi-Symptom
Pain Relief

WITH
ALOE

Soothing Pain Relief from Burning,
Itching, & Discomfort
Shrinks Swollen Hemorrhoidal Tissue
Protects Irritated Tissue
Relieves External Discomfort
Proprietary Blend with Vitamin E
and Aloe

1 TUBE | NET WT 1.8 OZ (51 g)

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98
PREPARATION H  MAXIMUM STRENGTH
glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2868
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-23 (UNII: N72LMW566G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-2868-101 in 1 CARTON07/01/2004
126 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0573-2868-201 in 1 CARTON07/01/2004
251 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0573-2868-931 in 1 CARTON01/01/2019
326 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:0573-2868-981 in 1 CARTON05/12/2020
451 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/01/2004
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
PF Consumer Healthcare Canada ULC203812479ANALYSIS(0573-2868) , LABEL(0573-2868) , MANUFACTURE(0573-2868) , PACK(0573-2868)
Establishment
NameAddressID/FEIBusiness Operations
Pharmacia & Upjohn Company LLC618054084API MANUFACTURE(0573-2868)

Revised: 12/2022
Document Id: 7f958f48-333d-4145-b3ea-745f718e8fc9
Set id: 7cc03d2e-e708-589a-d9bb-58ebbda989c0
Version: 15
Effective Time: 20221222
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC