KISSABLE - Oatmeal daily moisturizing lotion (8 oz.)

OATMEAL DAILY MOISTURIZING 8OZ.- dimethicone lotion
BRANDS INTERNATIONAL

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.

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Active Ingredient Purpose

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

Skin protectant

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

Uses

Temporarily protects chafed, chapped or cracked skin

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

Directions apply liberally as often as needed.

Other Information store at room temperature.

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.

OATMEAL DAILY MOISTURIZING 8OZ.
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50157-612
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3 g in 227 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50157-612-22	227 g in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/22/2023

Labeler - BRANDS INTERNATIONAL (243748238)

Registrant - BRANDS INTERNATIONAL (243748238)

Name	Address	ID/FEI	Business Operations
Establishment
BRANDS INTERNATIONAL		243748238	manufacture(50157-612)