DailyMed - PH/LOCK LITE ECZEMA RELIEF GENTLE START- colloidal oatmeal emulsion

NDC Code(s): 85265-101-01
Packager: Soteri Skin, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 25, 2025

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Active Ingredient
Colloidal Oatmeal 1.5%

Colloidal Oatmeal 1.5%
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Purpose
Skin Protectant

Skin Protectant
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Uses
temporarily protect and helps relieve minor skin irritation and itching due to: eczema
temporarily protect and helps relieve minor skin irritation and itching due to:
- eczema
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Warnings
For external use only - When using this product - do not get into eyes - Stop use and ask doctor if - condition worsens - symptoms last more than 7 days or clear up and occur again within a few ...
For external use only

When using this product
- do not get into eyes
Stop use and ask doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Uses - Keep out of reach of children

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

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Directions
Apply twice per day, AM and PM and always after cleansing. Apply as needed.
- Apply twice per day, AM and PM and always after cleansing.
- Apply as needed.
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Inactive Ingredients
Water, Butyrospermum Parkii (Shea) Butter, Glycerin, Helianthus Annuus (Sunflower) Oil, Cetearyl Alcohol, Ceteareth-20, Oryza Sativa (Rice) Extract, Hydrolyzed Oat Protein, Dimethicone, Sodium ...

Water, Butyrospermum Parkii (Shea) Butter, Glycerin, Helianthus Annuus (Sunflower) Oil, Cetearyl Alcohol, Ceteareth-20, Oryza Sativa (Rice) Extract, Hydrolyzed Oat Protein, Dimethicone, Sodium Citrate, Camellia Sinensis Leaf Extract, Niacinamide, Glyceryl Laurate, Glutamic Acid, Aspartic Acid, Histidine, Citric Acid, Sodium Gluconate, Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Sodium Lauroyl Lactylate, Cholesterol, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Phenoxyethanol.
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Other Information
Store below 30C (86F)

Store below 30C (86F)
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Package Principal Display Panel
...

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INGREDIENTS AND APPEARANCE

Product Information

PH/LOCK LITE ECZEMA RELIEF GENTLE START colloidal oatmeal emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:85265-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
GLUTAMIC ACID (UNII: 3KX376GY7L)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE AP (UNII: F1X8L2B00J)
GLYCERYL LAURATE (UNII: Y98611C087)
WATER (UNII: 059QF0KO0R)
CERAMIDE 1 (UNII: 5THT33P7X7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
RICE GERM (UNII: 7N2B70SFEZ)
HISTIDINE (UNII: 4QD397987E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
CETEARETH-20 (UNII: YRC528SWUY)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
XANTHAN GUM (UNII: TTV12P4NEE)
OAT (UNII: Z6J799EAJK)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TEA LEAF (UNII: GH42T47V24)
ASPARTIC ACID (UNII: 30KYC7MIAI)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:85265-101-01	1 in 1 CARTON	02/17/2025
1		100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	02/17/2025

Labeler - Soteri Skin, Inc. (138344904)

Registrant - Creative Essences Inc (079120182)

Name	Address	ID/FEI	Business Operations
Establishment
Creative Essences Inc		079120182	manufacture(85265-101) , pack(85265-101) , label(85265-101)

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Published Date (What is this?)	Version	Files
Mar 27, 2025	3 (current)	download
Feb 21, 2025	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1654721	colloidal oatmeal 1.5 % Topical Cream	PSN
2	1654721	colloidal oatmeal 15 MG/ML Topical Cream	SCD
3	1654721	colloidal oatmeal 1.5 % Topical Cream	SY

Label: PH/LOCK LITE ECZEMA RELIEF GENTLE START- colloidal oatmeal emulsion

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Label: PH/LOCK LITE ECZEMA RELIEF GENTLE START- colloidal oatmeal emulsion

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Uses - Keep out of reach of children

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PH/LOCK LITE ECZEMA RELIEF GENTLE START- colloidal oatmeal emulsion

Number of versions: 2

PH/LOCK LITE ECZEMA RELIEF GENTLE START- colloidal oatmeal emulsion

PH/LOCK LITE ECZEMA RELIEF GENTLE START- colloidal oatmeal emulsion

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PH/LOCK LITE ECZEMA RELIEF GENTLE START- colloidal oatmeal emulsion

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.