AL0043600 ALBA BOTANICA VE HERBAL HEALING BODY- colloidal oatmeal lotion

AL0043600 Alba Botanica VE Herbal Healing Body by

Drug Labeling and Warnings

AL0043600 Alba Botanica VE Herbal Healing Body by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Colloidal Oatmeal - 0.4%

DOSAGE & ADMINISTRATION

Smooth over entire body after bathing and any time skin feels thirsty. Give special attention to areas under dry skin attack.

PURPOSE

Skin Protectant

WARNINGS

For external use only. Avoid contacts with eyes. Stop use and ask a doctor if symptoms last more than 7 days or condition worsens.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact Poison Center immediately.

INACTIVE INGREDIENT

Water, Helianthus Annuus (Sunflower) Seed Oil(1), Glycerin, Glyceryl Stearate SE, Butyrospermum Parkii (Shea) Butter (1), Cetyl Alcohol, Carthamus Tinctorius (Safflower)Seed Oil (1), Cocos Nucifera (Coconut) Oil (1), Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient

INDICATIONS & USAGE

Helps protect and relieve skin irritation and iching due to eczema, rashes, dry skin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AL0043600 ALBA BOTANICA VE HERBAL HEALING BODY 
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2436
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
SAFFLOWER OIL (UNII: 65UEH262IS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHAMOMILE (UNII: FGL3685T2X)
XANTHAN GUM (UNII: TTV12P4NEE)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2436-9	907 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/12/2017

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		014334364	manufacture(61995-2436)