Label: COATS ALOE- allantoin lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58826-702-02, 58826-702-08, 58826-702-33 - 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 November 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
- Purpose
- Warnings
- STOP USE
- DO NOT USE
- Uses
- Keep out of reach of children
- Directions
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Inactive Ingredients
aloe barbadenesis leaf juice, ethylhexyl palmitate, glycerin, methyl gluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolamine, stearice acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben
- COATS ALOE LOTION 8 OZ
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INGREDIENTS AND APPEARANCE
COATS ALOE
lotions, oils, powders, and creams lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58826-702 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) ALOE VERA LEAF (UNII: ZY81Z83H0X) BOROGLYCERIN (UNII: U3LMU4AN21) METHYL GLUCETH-20 (UNII: J3QD0LD11P) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TOCOPHEROL (UNII: R0ZB2556P8) LAURETH-4 (UNII: 6HQ855798J) LAURETH-23 (UNII: N72LMW566G) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color white (white lotion, can be off-white due to natural variation of aloe vera) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58826-702-08 237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 10/10/2015 2 NDC:58826-702-33 976 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 10/10/2015 3 NDC:58826-702-02 59 mL in 1 BOTTLE, DISPENSING; 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(58826-702)
