Label: GALENTIC HYDROGEL- glycerin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50382-013-15 - Packager: Galentic Pharma (India) Private Limited
- 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 19, 2018
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- Active Ingredient
- Purpose
- • USES
- • WARNINGS
- • DIRECTIONS
- • OTHER INFORMATION
- • INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 84.7 g Tube Label
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INGREDIENTS AND APPEARANCE
GALENTIC HYDROGEL
glycerin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 20 g in 100 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-013-15 24 in 1 CASE 04/14/2014 1 84.7 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 04/14/2014 Labeler - Galentic Pharma (India) Private Limited (915110464) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Private Limited 650970176 ANALYSIS(50382-013) , manufacture(50382-013) , PACK(50382-013) , REPACK(50382-013) , STERILIZE(50382-013)