Label: HEMAWAY- lidocane and phenylephrine hcl cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-180-01 - Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 6, 2010
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- INDICATIONS & USAGE
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WARNINGS
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
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Difficulty in urination due to enlargement of the prostate gland
- Rectal 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 right away.
When using this product
- 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
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DOSAGE & ADMINISTRATION
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.
- INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMAWAY
lidocane and phenylephrine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-180 Route of Administration TOPICAL 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)