SKIN SOOTHING CREAM- colloidal oatmeal cream

Skin Soothing Cream by

Drug Labeling and Warnings

Skin Soothing Cream by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc, Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Colloidal Oatmeal 1%

PURPOSE

Purpose: Skin Protectant

INDICATIONS & USAGE

Uses:

• Temporarily protects and helps relieve minor skin irritation and itiching du to rashes and eczema. 

WARNINGS

Warning: For external use only.

STOP USE

Stop use and ask a doctor: If condition worsens. Symptons last more than 7 days or clear up and appear again within a few days.

WHEN USING

When using this product - do not get into eyes.

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.

DOSAGE & ADMINISTRATION

Directions:

• Apply evenly to your skin. Apply lightly and use use 1-3 tomes a day as needed.

Other Information: Store below 30 C (68 F).

INACTIVE INGREDIENT

Inactive Ingredients: Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, hHoney, Aloe Barbadensis Leaf juice, Beeswax, Water (Aqua), Sodium Bicarbonate, Potassium Sorbate, Helianthus Annus (Sunflower) Seed Oil, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol.

QUESTIONS

Questions or Comments?

Call toll free 707-652-3438

mail: ariel@eczemahoneyco.com

PRINCIPAL DISPLAY PANEL

Manufactured For

Eczema Honey CO LLC.

Hayward, CA, 94545

INGREDIENTS AND APPEARANCE

SKIN SOOTHING CREAM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4190
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
ALMOND OIL (UNII: 66YXD4DKO9)
HONEY (UNII: Y9H1V576FH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4190-1	113.5 g in 1 TUBE; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/24/2020

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4190)