SOOTHE SENSITIVE SKIN TREATMENT- allantoin, dimethicone lotion

SOOTHE Sensitive Skin Treatment by

Drug Labeling and Warnings

SOOTHE Sensitive Skin Treatment by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Allantoin 0.5%

Dimethicone 2.9%

Purpose

Skin protectant

Uses

• temporarily protects and helps relieve chapped or cracked skin
• helps protect from the drying effects of wind and cold weather

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

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a thin, even layer over the entire face, avoiding the eye area. Do not rinse off. Use twice daily. Apply as needed.

Inactive ingredients

Water/Aqua/Eau, Glycerin, Isododecane, Sodium Acrylates Copolymer, Oryza Sativa (Rice) Bran Extract, Chamomilla Recutita (Matricaria) Flower Extract, Pelargonium Graveolens Flower Oil, Lavandula Angustifolia (Lavender) Oil, Boswellia Serrata Extract, Oligopeptide-10, Tetrapeptide-16, Tocopherol, Tropolone, Tranexamic Acid, Honey Extract, Glycine Soja (Soybean) Germ Extract, Perilla Ocymoides Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Bisabolol, Angelica Polymorpha Sinensis Root Extract, Linoleic Acid, Linolenic Acid, Butylene Glycol, Coco-Caprylate/Caprate, Decyl Glucoside, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Hydrogenated Polyisobutene, Lysolecithin, PEG-40 Stearate, Phospholipids, Polyglyceryl-10 Stearate, Polysilicone-11, Xanthan Gum, Hexylene Glycol, Tin Oxide, 1,2-Hexanediol, Caprylyl Glycol, Chlorhexidine Digluconate, Chlorphenesin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citronellol, Geraniol, Linalool, Mica, Titanium Dioxide (CI 77891).

Other information

• Store between 15-30 ºC (59-86 ºF),
  Do not refrigerate.

Principal Display Panel - Soothe Sensitive Skin Treatment Tube Label

RODAN+FIELDS®
SOOTHE

2

Sensitive Skin
Treatment

Principal Display Panel - Soothe Sensitive Skin Treatment Carton Label

RODAN+FIELDS®
SOOTHE

2

Sensitive
Skin
Treatment

RODAN+FIELDS®

Skin Protectant

50 mL/1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

SOOTHE SENSITIVE SKIN TREATMENT 
allantoin, dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-1005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	0.5 g  in 100 mL
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Isododecane (UNII: A8289P68Y2)
Rice Bran (UNII: R60QEP13IC)
Chamomile (UNII: FGL3685T2X)
Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)
Lavender Oil (UNII: ZBP1YXW0H8)
Indian Frankincense (UNII: 4PW41QCO2M)
Oligopeptide-10 (UNII: Q46328TRNK)
Tocopherol (UNII: R0ZB2556P8)
Tropolone (UNII: 7L6DL16P1T)
Tranexamic Acid (UNII: 6T84R30KC1)
Honey (UNII: Y9H1V576FH)
Soybean Germ (UNII: JBW2VHD14M)
Perilla Frutescens Seed Oil (UNII: 322MS57V7Z)
Sunflower Oil (UNII: 3W1JG795YI)
Levomenol (UNII: 24WE03BX2T)
Angelica Sinensis Root (UNII: B66F4574UG)
Linoleic Acid (UNII: 9KJL21T0QJ)
Linolenic Acid (UNII: 0RBV727H71)
Butylene Glycol (UNII: 3XUS85K0RA)
Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)
Decyl Glucoside (UNII: Z17H97EA6Y)
Hydrogenated Polybutene (1300 MW) (UNII: 7D1YQ9Y5EZ)
PEG-40 Stearate (UNII: ECU18C66Q7)
Lecithin, Soybean (UNII: 1DI56QDM62)
Polyglyceryl-10 Stearate (UNII: 90TF85HH91)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Xanthan Gum (UNII: TTV12P4NEE)
Hexylene Glycol (UNII: KEH0A3F75J)
Stannic Oxide (UNII: KM7N50LOS6)
1,2-Hexanediol (UNII: TR046Y3K1G)
Caprylyl Glycol (UNII: 00YIU5438U)
Chlorhexidine Gluconate (UNII: MOR84MUD8E)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)
.Beta.-Citronellol, (R)- (UNII: P01OUT964K)
Geraniol (UNII: L837108USY)
Linalool, (+/-)- (UNII: D81QY6I88E)
Mica (UNII: V8A1AW0880)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-1005-1	1 in 1 BOX	06/01/2017
1	NDC: 14222-1005-0	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2017

Labeler - Rodan & Fields (051659584)