HEMORRHOIDAL- glycerin, lidocaine cream

Hemorrhoidal by

Drug Labeling and Warnings

Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by VELOCITY PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Glycerin 14.4%	Protectant
Lidocaine 5%	Local anesthetic

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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 6 times daily, especially at night, in the morning or after each bowel movement
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

store at 20–25°C (68–77°F)

INACTIVE INGREDIENT

Inactive ingredients

aloe vera gel, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propylene glycol, propylparaben, purified water, stearyl alcohol, white soft paraffin, xanthan gum

QUESTIONS

Questions or comments?

Call 888-309-9030

PRINCIPAL DISPLAY PANEL 

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL 
glycerin, lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-403
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

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)
PETROLATUM (UNII: 4T6H12BN9U)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
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: 76168-403-01	1 in 1 CARTON	06/04/2019
1		30 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	06/04/2019

Labeler - VELOCITY PHARMA LLC (962198409)