Hemorrhoid Relief by Velocity Pharma LLC Hemorrhoid relief cream

Drug Details [pdf]

HEMORRHOID RELIEF- glycerin, lidocaine, phenylephrine hcl and white petrolatum cream
Velocity Pharma 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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Hemorrhoid relief cream

Drug Facts

Active ingredients	Purposes
Glycerin	Protectant
Lidocaine	Local anesthetic
Phenylephrine HCl	Vasoconstrictor
White Petrolatum	Protectant

Uses

for temporary relief of pain, soreness and burning
helps relieve the local itching and discomfort associated with hemorrhoids
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

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

rectal 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 this cream.
apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
children under 12 years of age: ask a doctor

Other information

store at 20–25°C (68–77°F)

Inactive ingredients

aloe vera gel, benzyl alcohol, butylated hydroxy toluene, carboxymethylcellulose sodium, cetomacrogol 1000, cetyl alcohol, cetyl alcohol, citric acid, disodium EDTA, glyceryl monostearate, light liquid paraffin, propylene glycol, purified water, stearyl alcohol, Vitamin E, xanthan gum

Questions or comments?

Call 1-855-314-1850

Package Label

HEMORRHOID RELIEF
glycerin, lidocaine, phenylephrine hcl and white petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-323
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	150 mg in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	144 mg in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76168-323-30	1 in 1 CARTON	10/25/2020	02/01/2021
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	10/25/2020	02/01/2021

Labeler - Velocity Pharma LLC (962198409)

Revised: 3/2021

Document Id: bd117a1e-ed37-0373-e053-2995a90a27b8

Set id: b29bc9cb-9b58-3c32-e053-2a95a90a2b13

Version: 2

Effective Time: 20210308