HEALING ECZEMA BALM- oatmeal cream
PROVINCE APOTHECARY 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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HEALING ECZEMA BALM 15G 80G

HEALING ECZEMA BALM

Drug Facts

Active Ingredients

Colloidal Oatmeal 1 %

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:
- eczema
- rashes

Warnings

For external use only

When using this product

Do not get into eyes.

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 product is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply to affected areas of skin as needed
Massage into extremely dry, cracked and chafed skin as often as needed for instant relief and long-lasting hydration. Apply generously.

Inactive ingredients

Olea Europaea (Olive) Oil, Zinc Oxide, Cera Alba (Beesawax), Calendula Officinalis Flower Oil, Borago Officinalis (Borage) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Symphytum Officinale (Comfrey) Root Extract, Brassica Oleracea Italica (Broccoli) Seed Oul, Rosa Canina (Rosehip) Fruit Oil, Tocopherol (Vitamin E), Hypericum Perforatum (St.John's Wort) Oil, Propolis Cera, Curcuma Longa (Turmeric) Root Oil.

HEALING ECZEMA BALM 15g (72257-001-15)

HEB_15

ECZEMA BALM 80g (72257-001-80)

HEB_80g

Drug Facts

DrugFacts1

DrugFacts2

HEALING ECZEMA BALM
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72257-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
OLIVE OIL (UNII: 6UYK2W1W1E)
ZINC OXIDE (UNII: SOI2LOH54Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COMFREY ROOT (UNII: M9VVZ08EKQ)
BROCCOLI SEED OIL (UNII: SY01LVD4G4)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
TURMERIC OIL (UNII: 6KGS8SP16U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72257-001-15	1 in 1 BOX	09/11/2018
1		15 g in 1 JAR; Type 0: Not a Combination Product
2	NDC:72257-001-80	1 in 1 BOX	09/11/2018
2		80 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	09/11/2018

Labeler - PROVINCE APOTHECARY INC (201115232)

Registrant - PROVINCE APOTHECARY INC (201115232)

Revised: 1/2022

Document Id: d62cc9cc-e93f-0ed5-e053-2995a90ace98

Set id: 4a6ab3ce-14e4-419b-9f76-84deac708266

Version: 4

Effective Time: 20220101

PROVINCE APOTHECARY INC