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

pH/Lock Lite Eczema Relief Gentle Start by

Drug Labeling and Warnings

pH/Lock Lite Eczema Relief Gentle Start by is a Otc medication manufactured, distributed, or labeled by Soteri Skin, Inc., Creative Essences Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Colloidal Oatmeal 1.5%

Purpose

Skin Protectant

Uses

temporarily protect and helps relieve minor skin irritation and itching due to:

• eczema

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 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.

Directions

• Apply twice per day, AM and PM and always after cleansing.
• Apply as needed.

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 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.

Other Information

Store below 30C (86F)

Package Principal Display Panel

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	7 g  in 100 mL
NIACINAMIDE (UNII: 25X51I8RD4)	0.5 g  in 100 mL
GLUTAMIC ACID (UNII: 3KX376GY7L)	0.2 g  in 100 mL
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)	8.5 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 g  in 100 mL
CERAMIDE AP (UNII: F1X8L2B00J)	0.006 g  in 100 mL
GLYCERYL LAURATE (UNII: Y98611C087)	0.5 g  in 100 mL
WATER (UNII: 059QF0KO0R)	55.892 g  in 100 mL
CERAMIDE 1 (UNII: 5THT33P7X7)	0.006 g  in 100 mL
CHOLESTEROL (UNII: 97C5T2UQ7J)	0.02 g  in 100 mL
CITRIC ACID (UNII: 2968PHW8QP)	0.3 g  in 100 mL
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)	0.2 g  in 100 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.35 g  in 100 mL
CETEARYL ALCOHOL (UNII: 2DMT128M1S)	4 g  in 100 mL
RICE GERM (UNII: 7N2B70SFEZ)	2.5 g  in 100 mL
HISTIDINE (UNII: 4QD397987E)	0.5 g  in 100 mL
SODIUM GLUCONATE (UNII: R6Q3791S76)	0.3 g  in 100 mL
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)	7 g  in 100 mL
CETEARETH-20 (UNII: YRC528SWUY)	3.7 g  in 100 mL
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)	0.02 g  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.5 g  in 100 mL
OAT (UNII: Z6J799EAJK)	2 g  in 100 mL
DIMETHICONE (UNII: 92RU3N3Y1O)	1.5 g  in 100 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR)	1 g  in 100 mL
TEA LEAF (UNII: GH42T47V24)	0.75 g  in 100 mL
ASPARTIC ACID (UNII: 30KYC7MIAI)	0.2 g  in 100 mL
CERAMIDE NP (UNII: 4370DF050B)	0.006 g  in 100 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.35 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/17/2025

Labeler - Soteri Skin, Inc. (138344904)

Registrant - Creative Essences Inc (079120182)

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