Label: COATS ALOE- allantoin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58826-703-04, 58826-703-16 - Packager: TYCHASIS CORPORATION
- 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 9, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Uses:
- Warnings
- Uses:
- Caution:
- Keep out of reach of children
- Directions:
- Directions:
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Inactive Ingredients:
water, aloe barbadensis leaf juice, caprylic/-capric triglyceride, cetyl alcohol, postassium palmitoyl hydrolyzed wheat protein, glycerol stearate, pentylene glycol, butyrospermum parkii (shea) butter, c12-15 alkyl benzoate, glycerin, beta-glucan, sodium hyaluronate, glyceryl stearate SE, cetearath-20, dehydroacetic acid, benzyl alcohol
- Questions:
- Package Label: COATS ALOE CREME 4 OZ
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INGREDIENTS AND APPEARANCE
COATS ALOE
allantoin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58826-703 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 Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) PENTYLENE GLYCOL (UNII: 50C1307PZG) WATER (UNII: 059QF0KO0R) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) POTASSIUM PALMITATE (UNII: KTC40CLC68) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) SHEA BUTTER (UNII: K49155WL9Y) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DEHYDROACETIC ACID (UNII: 2KAG279R6R) BENZYL ALCOHOL (UNII: LKG8494WBH) Product Characteristics Color white (thick white creme, can sometimes be off-white due to natural characteristics of aloe vera) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58826-703-04 118 g in 1 JAR; Type 0: Not a Combination Product 10/10/2015 2 NDC:58826-703-16 454 g in 1 JAR; Type 0: Not a Combination Product 10/10/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/10/2015 Labeler - TYCHASIS CORPORATION (022731149) Registrant - TYCHASIS CORPORATION (022731149) Establishment Name Address ID/FEI Business Operations BIOMED LABORATORIES 055329696 manufacture(58826-703)