Label: OATMEAL DAILY MOISTURIZING 8OZ.- dimethicone lotion

  • 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 February 22, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Dimethicone 1.3% ......... Skin Protectant

  • PURPOSE

    Skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Uses

    • Temporarily protects chafed, chapped or cracked skin

  • WARNINGS

    Warnings For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • DOSAGE & ADMINISTRATION

    Directions apply liberally as often as needed.

  • OTHER SAFETY INFORMATION

    Other Information store at room temperature.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Isopropyl Myristate, Glycerin, Cetyl Alcohol, Mineral Oil, Fragrance, DMDM Hydantoin, Stearyl Alcohol, Carbomer, Sodium Hydroxide, Aloe Vera Leaf, Vitamin E, Isopropyl Myristate.

  • PRINCIPAL DISPLAY PANEL

    4

  • INGREDIENTS AND APPEARANCE
    OATMEAL DAILY MOISTURIZING 8OZ. 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-612
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
    WATER (UNII: 059QF0KO0R)  
    .BETA.-ELEOSTEARIC ACID (UNII: LA17B88161)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-612-22227 g in 1 BOTTLE; Type 0: Not a Combination Product02/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/22/2023
    Labeler - BRANDS INTERNATIONAL (243748238)
    Registrant - BRANDS INTERNATIONAL (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    BRANDS INTERNATIONAL243748238manufacture(50157-612)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!