HEMAWAY- lidocaine 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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HemAway Maximum Strength Hemorrhoid Relief Cream

Uses

Temporarily relieves pain, itching and discomfort due to anorectal disorders.

Warnings

For External use only

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

Lidocaine 5%

Local anesthetic

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

Ask a Doctor before use, if you have:

Stop use and ask a Doctor if:

Ask a Doctor or Pharmacist 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 this product:

TubeBox

HEMAWAY 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-336
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1.5 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-336-011 in 1 BOX08/04/2020
1NDC:54473-336-3030 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/04/2020
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.805617610manufacture(54473-336)

Revised: 1/2023
Document Id: f205b4ae-b262-34d9-e053-2a95a90a7f19
Set id: cf842adf-fcd7-2c8c-e053-2995a90adea6
Version: 2
Effective Time: 20230111
 
Melaleuca, Inc.