NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL by

Drug Labeling and Warnings

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL by is a Otc medication manufactured, distributed, or labeled by 7774672 CANADA INC, EUROPE SKIN CARE AVENUE CORP, LABORATOIRES DRUIDE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 ML- titanium dioxide, zinc oxide cream 
7774672 CANADA INC

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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NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL

DRUG FACTS

Active Ingredients

Colloidal Oatmeal 1.3%

Purpose

Skin Protectant

Uses

▪ Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

Warnings

For external use only

Do not use

Consult a healthcare practitioner if symptoms worsen or last for more than 7 days.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children

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

Directions

▪ Apply to affected area as needed.

Other Information

Protect the product in this container from excessive heat and direct sun. Store the product at room temperature 20 to 25°C (68 to 77°F).

Inactive Ingredients

Aloe Barbadensis Leaf Juice*, C10-18 Triglycerides, Oenothera Biennis (Evening Primrose) Oil*, Coco-Caprylate, Curcuma Longa Extract*, Propanediol, Polyglycery1-6 Distearate, Crataegus Oxyacantha Extract*, Crataegus oxyacantha (hawthorn), Glyceryl Stearate (2%), Nelumbo Nucifera Root Water, Jojoba Esters, Aspalathus Linearis Leaf Extract*, Sodium Stearoyl Glutamate, Polyglyceryl-3 Beeswax, Glycerin, Cetyl Alcohol, Tocopherol (Vitamin E), Salicylic Acid, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Illicium Verum (Anise) Fruit/Seed Oil* , Sorbic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Oil*, Glycogen.

*Certified organic .

Questions or Comments?

1-800-263-8888

Outside Canada or the United States dial 514-333-8282 or visit www.nellydevuyst.com

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL (NDC: 58416-032-00)

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 ML 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58416-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE (UNII: 4828G836N6)
TURMERIC (UNII: 856YO1Z64F)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
NELUMBO NUCIFERA ROOT OIL (UNII: 382005USDH)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
TOCOPHEROL (UNII: R0ZB2556P8)
SALICYLIC ACID (UNII: O414PZ4LPZ)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STAR ANISE FRUIT (UNII: CK15HA8438)
SORBIC ACID (UNII: X045WJ989B)
TEA TREE OIL (UNII: VIF565UC2G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GINGER OIL (UNII: SAS9Z1SVUK)
GLYCOGEN (UNII: 309GSC92U1)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58416-032-01	1 in 1 BOX	06/21/2021
1	NDC: 58416-032-00	30 g 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	06/21/2021	06/21/2021

Labeler - 7774672 CANADA INC (203095039)

Registrant - 7774672 CANADA INC (203095039)

Establishment
Name	Address	ID/FEI	Business Operations
EUROPE SKIN CARE AVENUE CORP		117190623	pack(58416-032)

Establishment
Name	Address	ID/FEI	Business Operations
7774672 CANADA INC		203095039	pack(58416-032)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(58416-032)

Revised: 1/2022

Document Id: e46d0aae-cdea-ed47-e053-2995a90ac719

34390-5

Set id: c5ca14ef-bbb3-e1a2-e053-2995a90af8ed

Version: 3

Effective Time: 20220101