YELLOW- shea butter, allantoin lotion 
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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Yellow Lotion (Shea Butter)

Active Ingredients

Shea Butter (11%)

Allantoin (2%)

Purpose

Skin Protectant

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 and toning the face, apply the adequate amount on skin.

Inactive Ingredients

Castor oil, Camellia oil, Emulsifying wax, Distilled Water, Rose water, Glycerin, Vitamin E oil, Optiphen plus, Fruity Fusion Fragrance oil

Keep out of reach of children

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

Yellow Lotion (Shea Butter Lotion)

yellow lotion (shea butter lotion)

YELLOW 
shea butter, allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71547-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.4 g  in 20 mL
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER2.2 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CAMELLIA OIL (UNII: T1PE06G0VE)  
CASTOR OIL (UNII: D5340Y2I9G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71547-110-021 in 1 PACKAGE07/24/2017
1NDC:71547-110-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/24/2017
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(71547-110)

Revised: 7/2017
Document Id: 552b1532-4a4f-2984-e054-00144ff8d46c
Set id: 5515993d-5a71-1dd1-e054-00144ff8d46c
Version: 6
Effective Time: 20170725
 
Iruri Nature Handmade Soap & Cosmetic Inc