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.

1

2

SOOTHE YOUR SKIN 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72683-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72683-007-01100 g in 1 JAR; Type 0: Not a Combination Product08/23/202112/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/23/202112/20/2022
Labeler - PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA (081214985)
Establishment
NameAddressID/FEIBusiness Operations
SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag401476254manufacture(72683-007)

Revised: 12/2022
 
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