SOOTHE MOISTURIZING RESCUE CREAM- oatmeal cream

SOOTHE Moisturizing Rescue Cream by

Drug Labeling and Warnings

SOOTHE Moisturizing Rescue Cream by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Colloidal

Oatmeal 1 %

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to rashes eczema.

Warnings

For external use only.

When using this product

• do not get into eyes.

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.

Keep out of reach of children.

If product is swallowed, get medical help right away.

Directions

Apply an even layer over face and neck as needed. Avoid eye area. Use AM + PM after Sensitive Skin Treatment.

Inactive Ingredients

Aqua/Eau/Water, Ascorbyl Palmitate, Behenic Acid, Butyrospermum Parkii (Shea) Butter, C12-16 Alcohols, Calcium Gluconate, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Curcuma Wenyujin/Curcuma Kwangsiensis Rhizome Extract, Cynara Scolymus (Artichoke) Leaf Extract, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Hydrogenated Lecithin, Lecithin, Maltodextrin, Ophiopogon Japonicus Root Extract, Opuntia Ficus-lndica Fruit Extract, Palmitic Acid, Panthenol, Phenoxyethanol, Polysilicone-11, Potassium Sorbate, Propanediol, Sodium Acrylates Copolymer, Sodium Benzoate, Tocopherol, Xanthan Gum, Yeast Extract.

Questions?

1-888-995-5656

Principal Display Panel - 50 mL Carton Label

RODAN+FIELDS

SOOTHE

Moisturizing Rescue Cream

3

50 mL/ 1.7 Fl. Oz. U.S.

Colloidal Oatmeal Cream

Principal Display Panel - 50 mL Tube Label

RODAN+FIELDS

SOOTHE

Moisturizing Rescue Cream

3

Colloidal Oatmeal
Skin Protectant

INGREDIENTS AND APPEARANCE

SOOTHE MOISTURIZING RESCUE CREAM 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2430
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BEHENIC ACID (UNII: H390488X0A)
SHEA BUTTER (UNII: K49155WL9Y)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE NG (UNII: C04977SRJ5)
CETEARETH-25 (UNII: 8FA93U5T67)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CURCUMA KWANGSIENSIS ROOT (UNII: 2WSI2681TI)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
PALMITIC ACID (UNII: 2V16EO95H1)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2430-1	1 in 1 CARTON	03/09/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 14222-2430-2	1 in 1 CARTON	06/01/2021
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 14222-2430-3	2 mL in 1 PACKET; Type 0: Not a Combination Product	04/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/09/2021

Labeler - Rodan & Fields (051659584)