Label: EM SHEA BUTTER CREAM- shea butter cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71547-102-01, 71547-102-02 - Packager: Iruri Nature Handmade Soap & Cosmetic Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated July 13, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
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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 cutStop use and ask a doctor if
- Rash or irritation on skin develops and lasts
- Directions
- Inactive ingredients
- EM Shea Butter Cream
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INGREDIENTS AND APPEARANCE
EM SHEA BUTTER CREAM
shea butter creamProduct 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)