HEMORRHOIDAL RELIEF CREAM- lidocaine cream 
Cardinal Health

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.

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

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

When using this product

  • avoid contact with eyes
  • 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

Stop use and ask a doctor if

  • retal 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

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 (1-800-222-1222) right away.

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.

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

  • Store at 20-25 0C (68-77 oF)
  • to secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.

Questions & Comments? 516-444-5749

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BoxTube

HEMORRHOIDAL RELIEF CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0468
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 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:70000-0468-11 in 1 BOX09/01/201903/31/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/15/201903/31/2023
Labeler - Cardinal Health (063997360)
Registrant - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.805617610manufacture(70000-0468)

Revised: 1/2023
Document Id: f34200f3-289c-6a0c-e053-2a95a90a9156
Set id: 902f2390-d662-526d-e053-2995a90a7905
Version: 3
Effective Time: 20230127
 
Cardinal Health