Your browser does not support JavaScript! HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]
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HEMAWAY (lidocane and phenylephrine hcl) cream
[Melaleuca, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Uses

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

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

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.

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

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

image of box

HEMAWAY 
lidocane and phenylephrine hcl cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54473-180
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE50 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
Benzyl Alcohol 
CARBOMER HOMOPOLYMER TYPE C 
CHOLESTEROL 
HYDROGENATED SOYBEAN LECITHIN 
ISOPROPYL MYRISTATE 
POLYSORBATE 80 
Propylene Glycol 
Water 
Trolamine 
ALPHA-TOCOPHEROL ACETATE 
GRAPE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-180-011 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/13/2010
Labeler - Melaleuca, Inc. (139760102)
Registrant - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.805617610manufacture(54473-180)

Revised: 12/2010
 
Melaleuca, Inc.

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