Label: HEMAWAY - lidocaine and phenylephrine hydrochloride cream
- NDC Code(s): 54473-180-01
- Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- INDICATIONS & USAGE
Temporarily relieves pain, itching and discomfort due to anorectal disorders and temporarily shrinks hemorrhoidal tissue.Close
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
- 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
- DOSAGE & ADMINISTRATION
- 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
- To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
- Tamper-Evident: do not use if foil seal under cap is broken or missing.
- See crimp of tube for lot number and expiration date.
- INACTIVE INGREDIENT
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 ExtractClose
- ACTIVE INGREDIENT
Active Ingredients PurposeClose
Lidocaine 5%...............................Local anesthetic
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.Close
- INGREDIENTS AND APPEARANCE
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)