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 Type HUMAN OTC DRUG Item Code (Source) NDC:54473-180
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 12/2010
Document Id: 7db048a3-6556-41d8-a5fe-b75e462d266e
Set id: 9e1f7343-17c7-45f8-963d-ba1a21d4b0f1
Version: 1
Effective Time: 20101206
 
Melaleuca, Inc.