Label: AUBIO LIFE SCIENCES LIP- allantoin and lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70365-001-01 - Packager: Aubio Life Sciences LLC
- 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 January 31, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Questions or comments?
- Directions
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Inactive Ingredients
Water (Aqua), Glycerin, Sarracenia Stalk/Flower/Seed Extract (and) Sarracenia Purpurea Leaf/Stalk/ Flower/Seed Extract, Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Flower Extract, Melissa Officinalis (Balm Mint) Extract, Dipotassium Glycyrrhizate, Phytosphingosine, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Xantham Gum, Sodium Hydroxide, Sodium Lauroyl Lactylate, Hexylene Glycol, Ethylhexylglycerin, Caprylyl Glycol, Phenoxytehanol
- Other Information
- Principal Display Panel - Blister Pack Label
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INGREDIENTS AND APPEARANCE
AUBIO LIFE SCIENCES LIP
allantoin and lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70365-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 5 mg in 1 g Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine 5 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Aloe vera Leaf (UNII: ZY81Z83H0X) Carbomer Interpolymer Type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO) Phenoxyethanol (UNII: HIE492ZZ3T) Caprylic Alcohol (UNII: NV1779205D) Ethylhexylglycerin (UNII: 147D247K3P) Hexylene Glycol (UNII: KEH0A3F75J) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Phytosphingosine (UNII: GIN46U9Q2Q) Sodium Lauroyl Lactylate (UNII: 7243K85WFO) Xanthan Gum (UNII: TTV12P4NEE) Cholesterol (UNII: 97C5T2UQ7J) Ceramide NP (UNII: 4370DF050B) 3-Dehydroxy Ceramide 1 (UNII: CR0J8RN66K) Ceramide AP (UNII: F1X8L2B00J) Lavandula Angustifolia Flower (UNII: 19AH1RAF4M) Melissa Officinalis (UNII: YF70189L0N) Sarracenia Purpurea (UNII: FOP08H143P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70365-001-01 3 g in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/28/2016 Labeler - Aubio Life Sciences LLC (080080743) Establishment Name Address ID/FEI Business Operations KLEEN CONCEPTS 012989797 MANUFACTURE(70365-001) , LABEL(70365-001)