EM SHEA BUTTER CREAM- shea butter cream 
Iruri Nature Handmade Soap & Cosmetic Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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EM Shea Butter Cream

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

EM Shea Butter Cream

EM SHEA BUTTER CREAM 
shea butter cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71547-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER5.14 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71547-102-021 in 1 PACKAGE07/13/2017
1NDC:71547-102-0120 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/13/2017
Labeler - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)
Registrant - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)
Establishment
NameAddressID/FEIBusiness Operations
Iruri Nature Handmade Soap & Cosmetic Inc095675041manufacture(71547-102)

Revised: 7/2017
Document Id: 543b6f9c-35ee-19da-e054-00144ff8d46c
Set id: 54002ed4-7066-3d71-e054-00144ff8d46c
Version: 4
Effective Time: 20170713
 
Iruri Nature Handmade Soap & Cosmetic Inc