Soothe your skin by PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA / SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag Soothe your skin

Soothe your skin by

Drug Labeling and Warnings

Soothe your skin by is a Otc medication manufactured, distributed, or labeled by PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA, SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOOTHE YOUR SKIN- colloidal oatmeal cream 
PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA

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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Soothe your skin

Active ingredient

Colloidal Oatmeal 1%

Purpose

Colloidal Oatmeal 1%...........Skin Protectant

Uses

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

Warnings

For external use only. Use only as directed.

Keep away from excessive heat or flame.

When using this product:

• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop use and ask a doctor if:

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days.

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

Directions

Adults and children 3 months of age and older: Apply as needed.

For children under 3 months of age: Consult a doctor.

Other information

• Store in a cool, dry place.
• Tamper-evident for your protection. Use only if safety seal is intact.

Inactive ingredients

Water, Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Glycerin, Tocopheryl (Vitamin E) Acetate, Undecane, Glyceryl Stearate, Panthenol, Triticum Vulgare (Wheat) Germ Oil, Squalane, Pentylene Glycol, Cetearyl Alcohol, Polyglyceryl-6 Palmitate/Succinate, Tridecane, Hydroxyacetophenone, Sodium Lactate, Sodium PCA, Glycine, Fructose, Urea, Niacinamide, Sodium Benzoate, Lactic Acid, Xylitylglucoside, Anhydroxylitol, Xylitol, Tocopherol, Decyl Glucoside

Questions or Comments?

888-819-6472

Monday-Friday, 9am-5pm CT

Report any serious side effects to number above.

NDC: 72683-007-01

Asutra*

Soothe your skin

1% Colloidal Oatmeal

Eczema Cream Skin Protectant

3.4 fl oz. | 100 ml.

SOOTHE YOUR SKIN 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72683-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
FRUCTOSE (UNII: 6YSS42VSEV)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UNDECANE (UNII: JV0QT00NUE)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PANTHENOL (UNII: WV9CM0O67Z)
WHEAT GERM OIL (UNII: 14C97E680P)
SQUALANE (UNII: GW89575KF9)
TRIDECANE (UNII: A3LZF0L939)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
GLYCINE (UNII: TE7660XO1C)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
UREA (UNII: 8W8T17847W)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
POLYGLYCERYL-2 PALMITATE (UNII: V2A5PDC572)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72683-007-01	100 g in 1 JAR; Type 0: Not a Combination Product	08/23/2021	12/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/23/2021	12/20/2022

Labeler - PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA (081214985)

Establishment
Name	Address	ID/FEI	Business Operations
SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag		401476254	manufacture(72683-007)

Revised: 12/2022

Document Id: f04b4731-e0e8-5524-e053-2995a90a5efc

34390-5

Set id: ca3b16f1-abe9-d7c8-e053-2995a90abe52

Version: 2

Effective Time: 20221220

 

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