Label: HEMORRHOIDAL RELIEF CREAM- lidocane cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-982-01, 69842-982-02 - Packager: CVS Pharmacy, 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 June 25, 2020
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- INDICATIONS & USAGE
- WARNINGS
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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
- ASK DOCTOR
- STOP USE
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL RELIEF CREAM
lidocane creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-982 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 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:69842-982-01 1 in 1 BOX 05/01/2017 1 NDC:69842-982-02 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/13/2010 Labeler - CVS Pharmacy, Inc (062312574) Registrant - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 805617610 manufacture(69842-982)