Label: HEMORRHOIDAL RELIEF CREAM- lidocane and glycerin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51316-333-01, 51316-333-28 - 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 October 8, 2021
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- Official Label (Printer Friendly)
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INDICATIONS & USAGE
Uses
- For temporary relief of pain, soreness and burning
- Helps relieve the local itching and discomfort associated with hemorrhoids
- Temporarily provides a coasting for relief of anorectal discomforts
- Temporarily portects the inflamed irritated anorectal surface to help make bowel movements less painful
- WARNINGS
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DOSAGE & ADMINISTRATION
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 this cream.
- Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement.
- Children under 12 years of age, ask a doctor
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- STOP USE
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL RELIEF CREAM
lidocane and glycerin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 4.032 g in 28 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 1.4 g in 28 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) WATER (UNII: 059QF0KO0R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-333-01 1 in 1 BOX 09/08/2021 1 NDC:51316-333-28 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 09/08/2021 Labeler - CVS Pharmacy, Inc (062312574) Registrant - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 805617610 manufacture(51316-333)