PURPLE- 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. ------Purple Lotion (Grape seed & Argan )

Active Ingredients Allantoin (2%)

Purpose Skin protectant

Uses Moisturizes skin. Helps to keep skin soft and clean.

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

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

Directions After cleansing and toning the face, apply the adequate amount on skin.

Inactive Ingredients , Grape , Argan oil, Emulsifying wax, Distilled Water, Lavender water, Glycerin, Vitamin E oil, Optiphen plus

Purple Lotion (Grape seed & Argan oil) PURPLE allantoin lotion

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:71547-10 9 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTO IN (UNII: 344S277G0 Z) (ALLANTOIN - UNII:344S277G0 Z) ALLANTOIN 0 .4 g in 20 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 0 59 QF0 KO0 R) GLYCERIN (UNII: PDC6 A3C0 OX) CASTO R O IL (UNII: D5340 Y2I9 G) GRAPE SEED O IL (UNII: 9 30 MLC8 XGG) ARGAN O IL (UNII: 4V59 G5UW9 X) .ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71547-10 9 -0 2 1 in 1 PACKAGE 0 7/25/20 17 1 NDC:71547-10 9 -0 1 20 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date unappro ved drug o ther 0 7/25/20 17

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

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

Establishment Name Addre ss ID/FEI Busine ss Ope rations Iruri Nature Handmade So ap & Co smetic Inc 0 9 56 750 41 manufacture(71547-10 9 )

Revised: 7/2017 Iruri Nature Handmade Soap & Cosmetic Inc