HEMAWAY- lidocane and phenylephrine hcl cream

HemAway by

Drug Labeling and Warnings

HemAway by is a Otc medication manufactured, distributed, or labeled by 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.

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 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 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.

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

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 doctor
  
  

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMAWAY 
lidocane and phenylephrine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-180
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: 54473-180-01	1 in 1 BOX
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/13/2010

Labeler - Melaleuca, Inc. (139760102)

Registrant - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		805617610	manufacture(54473-180)