HEM-EASY RELIEF HERBAL HEMORRHOIDAL- lidocaine hydrochloride cream 
Batool Pharma International, 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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HEM-EASY RELIEF Herbal Hemorrhoidal Cream

HEM-EASY RELIEF Herbal Hemorrhoidal Cream



Lidocaine HCL 4.50% / Local Anesthetic

Active Ingredient / Purpose:

Lidocaine HCL 4.50% / Local Anesthetic

Use For:

Temporary relief of anal itching and discomfort associated with hemorrhoids.

Warnings:

For external use only. Avoid contact with eyes. *Do not insert product into rectum using fingers or any mechanical device or applicator.

Ask a doctor before use, if you have

  • allergy or have allergic reaction to medications or ingredients in this product
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • Depression
  • difficulty in urination due to enlargement of the prostate gland

When using this product do not exceed the recommended daily dosage unless directed by a doctor.

Stop using and consult physician if

  • Condition worsens.
  • Bleeding occurs.
  • Symptoms persist for more than seven days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, contact physician or poison control center immediately.

Directions:

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe, Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
    • when first opening the tube, remove foil seal under the cap
    • apply to the affected area up to 2 times daily, especially at night, in the moming or after each bowel movement
    • regular use provides continual therapy for relief of symptoms
  • Children under 12 years of age: ask a doctor

Other information:

store at 20-25 C (68-77 F)

Any problems, concerns or issues, discontinue using the product and call your Doctor.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginians (Witch Hazel) Distillate, Melaleuca Aternifolia (Tea Tree) Oil, PEG-100 Stearate, Olea Europaea (Olive) Oil, Phenoxyethanol, Stearic Acid.

HEM-EASY RELIEF Herbal Hemorrhoidal Cream 60ml/2oz (69179-490-02)

HemEasyLabel
HEM-EASY RELIEF HERBAL HEMORRHOIDAL 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69179-490
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEG-100 STEARATE (UNII: YD01N1999R)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69179-490-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/201412/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/20/201412/31/2016
Labeler - Batool Pharma International, Inc (079242646)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(69179-490)

Revised: 1/2017
 
Batool Pharma International, Inc