Label: BALMEX ADULT CARE RASH- zinc oxide cream
- NDC Code(s): 52412-500-03, 52412-500-12
- Packager: Randob Labs,Ltd.
- 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 November 13, 2018
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- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021)
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
BALMEX ADULT CARE RASH
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52412-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.113 g in 1 g Inactive Ingredients Ingredient Name Strength Mineral Oil (UNII: T5L8T28FGP) Water (UNII: 059QF0KO0R) Yellow Wax (UNII: 2ZA36H0S2V) Microcrystalline Wax (UNII: XOF597Q3KY) Sorbitan Sesquioleate (UNII: 0W8RRI5W5A) Oenothera Biennis (UNII: 76UI55V071) Olea Europaea Leaf (UNII: MJ95C3OH47) Dimethicone 100 (UNII: RO266O364U) Tocopherol (UNII: R0ZB2556P8) Methylparaben (UNII: A2I8C7HI9T) Soybean Oil (UNII: 241ATL177A) Propylparaben (UNII: Z8IX2SC1OH) Dexpanthenol (UNII: 1O6C93RI7Z) Sarcosine (UNII: Z711V88R5F) Benzoic Acid (UNII: 8SKN0B0MIM) Potassium Aspartate (UNII: OC4598NZEQ) Potassium Hydroxide (UNII: WZH3C48M4T) Magnesium Aspartate Anhydrous (UNII: 082H981FMA) Sodium Cocoyl Glycinate (UNII: XLU9KH03XM) Propylene Glycol (UNII: 6DC9Q167V3) White Wax (UNII: 7G1J5DA97F) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52412-500-03 1 in 1 CARTON 11/01/2018 1 85 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:52412-500-12 340 g in 1 JAR; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 04/27/2015 Labeler - Randob Labs,Ltd. (061995007) Establishment Name Address ID/FEI Business Operations KIK HOLDCO COMPANY INC. 243547333 MANUFACTURE(52412-500)