EM SHEA BUTTER CREAM- shea butter cream

EM Shea Butter Cream by

Drug Labeling and Warnings

EM Shea Butter Cream by is a Otc medication manufactured, distributed, or labeled by Iruri Nature Handmade Soap & Cosmetic Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Shea Butter (25.7%)

Purpose

Skin protectant

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

Moisturizes skin.

Warnings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

- do not apply on other parts of the body
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut

Stop use and ask a doctor if

- Rash or irritation on skin develops and lasts

Directions

After cleansing face, apply the adequate amount on skin.

Inactive ingredients

Coconut oil, Castor oil, Bees wax, Cocoa butter, Emulsifying wax, Distilled water, E.M, Lavender essential oil, Vitamin E oil, Optiphen plus

EM Shea Butter Cream

INGREDIENTS AND APPEARANCE

EM SHEA BUTTER CREAM 
shea butter cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71547-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y)	SHEA BUTTER	5.14 g  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
COCONUT OIL (UNII: Q9L0O73W7L)
CASTOR OIL (UNII: D5340Y2I9G)
WATER (UNII: 059QF0KO0R)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71547-102-02	1 in 1 PACKAGE	07/13/2017
1	NDC: 71547-102-01	20 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/13/2017

Labeler - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)

Registrant - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)

Establishment
Name	Address	ID/FEI	Business Operations
Iruri Nature Handmade Soap & Cosmetic Inc		095675041	manufacture(71547-102)