Label: ALOE VESTA DAILY MOISTURIZER 118ML- dimethicone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11099-0004-4 - Packager: Guest Packaging 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 June 17, 2016
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DOSAGE & ADMINISTRATION
Directions For skin protection: • Apply as needed.
For diaper rash: • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
• Apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.
- Active ingredient
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- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ALOE VESTA DAILY MOISTURIZER 118ML
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11099-0004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 3.54 g in 118 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) GLYCERIN (UNII: PDC6A3C0OX) STEARETH-2 (UNII: V56DFE46J5) CETYL ALCOHOL (UNII: 936JST6JCN) BENZYL ALCOHOL (UNII: LKG8494WBH) LAURETH-23 (UNII: N72LMW566G) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11099-0004-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/09/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/09/2016 Labeler - Guest Packaging LLC. (001773076) Establishment Name Address ID/FEI Business Operations Guest Packaging LLC. 001773076 manufacture(11099-0004)