HEMORRHOIDAL RELIEF CREAM- lidocane and phenylephrine hcl cream

Hemorrhoidal Relief Cream by

Drug Labeling and Warnings

Hemorrhoidal Relief Cream by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc, Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Uses

Temporarily relieves pain, itching and discomfort due to anorectal disorders and temporarily shrinks hemorrhoidal tissue.

WARNINGS

Warnings

For External use only

Allergy alert: Certain persons can develop allergic reactions to ingredients in this product

DOSAGE & ADMINISTRATION

Directions

• Adults: when practical, cleanse the affected area with mild soap and warm water. Rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
• Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
• Children under 12 years of age: consult a doctor.
  

INFORMATION FOR PATIENTS

Other information

• To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
• Tamper-Evident: do not use if foil seal under cap is broken or missing.
• See crimp of tube for lot number and expiration date.
  

INACTIVE INGREDIENT

Inactive ingredients:  Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

ACTIVE INGREDIENT

Active Ingredients                              Purpose
Lidocaine 5%...............................Local anesthetic
Phenylephrine HCI.........................Vasoconstrictor

PURPOSE

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

ASK DOCTOR

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

STOP USE

Stop use and ask a doctor if

Rectal bleeding occurs
Condition worsens or does not improve within 7 days
Allergic reaction occurs
Symptoms clear up and return within a few days
Redness, irritation, swelling, pain or other symptoms begin or increase

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

If pregnant or breast-feeding, ask a health professional before use.

WHEN USING

When using this product

Do not put this product into the rectum by using fingers or any mechanical device or applicator
Do not exceed the recommended daily dosage unless directed by a doct

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL RELIEF CREAM 
lidocane and phenylephrine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-984
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPE (UNII: 6X543N684K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-984-01	1 in 1 BOX	05/01/2017
1	NDC: 69842-984-02	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	12/13/2010

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		805617610	manufacture(69842-984)