Label: OATMEAL DAILY MOISTURIZING 8OZ.- dimethicone lotion
- NDC Code(s): 50157-612-22
- Packager: BRANDS INTERNATIONAL
- 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
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OATMEAL DAILY MOISTURIZING 8OZ.
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50157-612 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 3 g in 227 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:50157-612-22 227 g in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/22/2023 Labeler - BRANDS INTERNATIONAL (243748238) Registrant - BRANDS INTERNATIONAL (243748238) Establishment Name Address ID/FEI Business Operations BRANDS INTERNATIONAL 243748238 manufacture(50157-612)