NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 ML- colloidal oatmeal cream 
LABORATOIRES DRUIDE 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 71447-030-00)

Nelly Devuys BioMedical Anti-Redness Serum 30 mL

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 ML 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71447-030-011 in 1 BOX10/14/2021
1NDC:71447-030-0030 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/14/2021
Labeler - LABORATOIRES DRUIDE INC (245815014)
Registrant - LABORATOIRES DRUIDE INC (245815014)
Establishment
NameAddressID/FEIBusiness Operations
LABORATOIRES DRUIDE INC245815014manufacture(71447-030)

Revised: 10/2021
Document Id: ce9fa5a8-dabe-6b55-e053-2995a90ae7c0
Set id: ce9fa5a8-dabd-6b55-e053-2995a90ae7c0
Version: 1
Effective Time: 20211014
 
LABORATOIRES DRUIDE INC