HEMAWAY - lidocaine and phenylephrine hydrochloride cream 
Melaleuca, Inc.

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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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

Stop use and ask a doctor if
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

Directions

Other information

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
Document Id: 7db048a3-6556-41d8-a5fe-b75e462d266e
Set id: 9e1f7343-17c7-45f8-963d-ba1a21d4b0f1
Version: 1
Effective Time: 20101206
 
Melaleuca, Inc.