PREPARATION H RAPID RELIEF- glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream 
Wyeth Consumer Healthcare 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® Rapid Relief

Drug Facts

Active ingredients Purposes
Glycerin 14.4% Protectant
Lidocaine 5% Local anesthetic
Phenylephrine HCl 0.25% Vasoconstrictor
White petrolatum 15% Protectant

Uses

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

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 - 23 g Tube Label

To open: push down on cap while turning counterclockwise.

Child-Resistant Cap

PREPARATION H®

HEMORRHOIDAL CREAM

RAPID RELIEF
WITH LIDOCAINE

NET WT 0.75 OZ (23g)

Principal Display Panel - 23 g Tube Label

PRINCIPAL DISPLAY PANEL - 23 g Tube Carton

PREPARATION H®

New Benefit
Now Reduces Swelling
See new label

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL
CREAM

LIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN
WHITE PETROLATUM

5%
HIGHEST STRENGTH
LIDOCAINE
AVAILABLE

1 TUBE | NET WT 0.75 OZ (23 g)

Principal Display Panel - 23 g Tube Carton
PREPARATION H RAPID RELIEF 
glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2843
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 144 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 150 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
LAURETH-23 (UNII: N72LMW566G)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-20 (UNII: L0Q8IK9E08)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0573-2843-01 1 in 1 CARTON 11/01/2018
1 23 g in 1 TUBE; Type 0: Not a Combination Product
2 NDC:0573-2843-10 1 in 1 CARTON 11/01/2018
2 28 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 11/01/2018
Labeler - Wyeth Consumer Healthcare LLC (828831730)
Establishment
Name Address ID/FEI Business Operations
PF Consumer Healthcare Canada ULC 203812479 ANALYSIS(0573-2843) , LABEL(0573-2843) , MANUFACTURE(0573-2843) , PACK(0573-2843)

Revised: 1/2019
Document Id: 213ae870-66b4-45c5-b7c2-422bf83ab050
Set id: 699310e8-1a93-40b4-a8f4-a765be4a0cb1
Version: 4
Effective Time: 20190122
 
Wyeth Consumer Healthcare LLC