INFLAMMATION THERAPY- calendula officinalis flowering top soap

Inflammation Therapy by

Drug Labeling and Warnings

Inflammation Therapy by is a Homeopathic medication manufactured, distributed, or labeled by Sundial Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Calendula Officinalis Extract - 1X	Reduces inflammation

INDICATIONS & USAGE

Uses: Reduces skin inflammation.

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions: Lather in hands or on a washcloth and wash entire body. Rinse thoroughly. Gentle enough for the face and for daily use.

SPL UNCLASSIFIED SECTION

Other information: For use on mild skin inflammation, or as directed by a physician.

INACTIVE INGREDIENT

Inactive ingredients: Sodium Palmate, Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Coconut Acid, Palmitic Acid, Sodium Chloride, Butyrospermum Parkii (Shea) Butter*, Titanium Dioxide (CI 77891), Aspalathus Linearis Leaf, Cannabis Sativa Seed Oil, Yellow 10 (CI 47005), Tetrasodium EDTA, Tetrasodium Etidronate, Iron Oxides (CI 77499), Melia Azadirachta Seed Oil, Red 4 (CI 14700), Green 3 (CI 42053).

*Certified Organic Ingredient

QUESTIONS

Questions or comments? 631-842-8800 or visit www.SheaMoisture.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INFLAMMATION THERAPY 
calendula officinalis flowering top soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58666-3121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT ACID (UNII: 40U37V505D)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SHEA BUTTER (UNII: K49155WL9Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
CANNABIS SATIVA SEED (UNII: QE567Z26NG)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE SODIUM (UNII: MP1J8420LU)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58666-3121-6	141 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2013

Labeler - Sundial Group LLC (832783430)