Label: BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL)- lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60608-016-00, 60608-016-01, 60608-016-02, 60608-016-03 - Packager: Bio-Scriptives, Inc.
- Category: HUMAN OTC DRUG LABEL
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 March 9, 2012
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Stop use and consult a doctor if:
- KEEP OUT OF REACH OF CHILDREN
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Directions
■ Children under 12 years of age: consult a doctor. ■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily.
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Inactive Ingredients
Aloe, Water, Cholesterol, Isopropyl Mysristate, Aqua, Caprylic/Capric Triglyceride, Propylene Glycol, Hydrogenated Phosphatidylcholine, Glyceryl Stearate, PEG-100 Stearate, Arginine HCI, Ethyl Oleate, Propylene Glycol, Tocophersolan, Cetyl Alcohol, Triethanolamine, Xanthan Gum, Tocopherol, Allantoin, Aloe Barbadensis Leaf, Methylisothiazolinone, Methyl Nicotinate
- Package and Lidum Images
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INGREDIENTS AND APPEARANCE
BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL)
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60608-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 2.8 g in 56 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) ETHYL OLEATE (UNII: Z2Z439864Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TOCOPHERSOLAN (UNII: O03S90U1F2) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) XANTHAN GUM (UNII: TTV12P4NEE) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) ALLANTOIN (UNII: 344S277G0Z) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYL NICOTINATE (UNII: 7B1AVU9DJN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60608-016-01 1 in 1 BOX 1 NDC:60608-016-00 56 g in 1 TUBE 2 NDC:60608-016-03 15 in 1 BOX 2 NDC:60608-016-02 4.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/04/2012 Labeler - Bio-Scriptives, Inc. (802946426) Establishment Name Address ID/FEI Business Operations Coastal Products Company 782445688 manufacture(60608-016)