Dove DermaSeries Eczema Relief Soothing Body lotion

Drug Labeling and Warnings

Drug Details [pdf]

DOVE DERMASERIES ECZEMA RELIEF SOOTHING BODY- colloidal oatmeal lotion 
Les Emballages Knowlton 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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Dove DermaSeries Eczema Relief Soothing Body lotion

Drug Facts

Active ingredients

Colloidal Oatmeal 1.0%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve minor skin irritation and itching due to:
• rashes  eczema 

Warnings

For external use only

When using this product do not get into eyes.

Stop use and ask a doctor if  condition worsens symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply as needed
• Massage into extremely dry, cracked and chafed skin as often as needed for instant relief and long-lasting hydration
• Apply generously onto dry skin and problem areas twice daily

Inactive ingredients

Water (Aqua), Glycerin, Stearic Acid, Isopropyl Palmitate, Glycol Stearate, PEG-100 Stearate, Mineral Oil, Dimethicone, Glyceryl Stearate, Petrolatum, Cetyl Alcohol, Phenoxyethanol, Methylparaben, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Propylparaben, Stearamide AMP, Disodium EDTA, Silk Amino Acids, Ascorbic Acid, Panthenol, Tocopheryl Acetate, Biotin, Niacinamide. 

Questions or comments?

1-800-761-3683

Clinically tested to soothe dry, itchy, irritated skin tested with dermatologists

Fragrance free  steroid free

Packaging

DOVE  DERMASERIES ECZEMA RELIEF SOOTHING BODY
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54565-1907
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCOL STEARATE (UNII: 0324G66D0E)
PEG-100 STEARATE (UNII: YD01N1999R)
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARAMIDE AMP (UNII: U3K8640346)
EDETATE DISODIUM (UNII: 7FLD91C86K)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BIOTIN (UNII: 6SO6U10H04)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54565-1907-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/13/2017
2	NDC: 54565-1907-2	200 mL in 1 TUBE; Type 0: Not a Combination Product	07/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/13/2017

Labeler - Les Emballages Knowlton Inc. (248704645)

Establishment
Name	Address	ID/FEI	Business Operations
Les Emballages Knowlton Inc.		248704645	manufacture(54565-1907)

Revised: 11/2017

Document Id: 5d8e0e94-b8e7-56db-e053-2991aa0a410f

34390-5

Set id: 5d8de051-d401-7de3-e053-2991aa0a7fad

Version: 1

Effective Time: 20171109

 

Les Emballages Knowlton Inc.