ATOA- rice bran extract cream 
PROSAFEBIO

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.

----------

ATOA
81745-301

purpose

Topical analgesic, Moisturizing, Skin protectant,Brightening

Use

Helps moistureize and relieve itching of dry skin.

Helps strengthen the weakened skin barrier.

Warnings

Do not use on damaged or broken skin.

Warnings

When using this product, do not use other than directed.

Warnings

Stop use and ask a doctor if irritation occurs.

Warnings

For external use only

Store at room temperature and avoid direct sunlight and high temperatures.

Warnings

Keep out of reach of children.

Directions

◾Take an appropriate amount and gently spread it over.

◾Reapply it frequently on the itchy area.

active ingredient

Rice Bran extract

Scutellaria baicalensis root extract

Opuntia humifusa stem extract

Sophora flavescens root extract

Angelica gigas root extract

Panax ginseng root extract

Inactive Ingredients

Purified water, Rice bran oil, Camellia Japonica Seed Oil, Sunflower seed oil, Glycerin, Butylene glycol, Simmondsia chinensis seed oil, Olive oil, Aloe baradensis leaf extract, Glyceryl caprylate, Centella Asiatica extract, Astragalus membranaceus root extract, Caprylyl glycol, Lavender oil, Sorbitan olivate, Xanthan gum, Ethylhexylglycerin, 1,2-Hexanediol, Disodium EDTA

Other information

Best before: 3 months after opening

Expiration date: indicated separately

Store at room temperature.

Question? Comments?

070-7576-2728

https://prosafebio.com

ATOA

LABEL

81745-301

ATOA

ATOA 
rice bran extract cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81745-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RICE BRAN (UNII: R60QEP13IC) (RICE BRAN - UNII:R60QEP13IC) RICE BRAN4 g  in 100 mL
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K) SOPHORA FLAVESCENS ROOT1 g  in 100 mL
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) (SCUTELLARIA BAICALENSIS ROOT - UNII:7J95K7ID2S) SCUTELLARIA BAICALENSIS ROOT1 g  in 100 mL
OPUNTIA HUMIFUSA WHOLE (UNII: 6E9O5V4SS5) (OPUNTIA HUMIFUSA WHOLE - UNII:6E9O5V4SS5) OPUNTIA HUMIFUSA WHOLE1 g  in 100 mL
ANGELICA GIGAS ROOT (UNII: 32766B2FHX) (ANGELICA GIGAS ROOT - UNII:32766B2FHX) ANGELICA GIGAS ROOT1 g  in 100 mL
ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASTRAGALUS PROPINQUUS ROOT POLYSACCHARIDES (UNII: 71WW2LNL50)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
RICE BRAN OIL (UNII: LZO6K1506A)  
WATER (UNII: 059QF0KO0R)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81745-301-01300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/07/2022
Labeler - PROSAFEBIO (695501710)
Registrant - PROSAFEBIO (695501710)
Establishment
NameAddressID/FEIBusiness Operations
PROSAFEBIO695501710manufacture(81745-301)

Revised: 10/2022
Document Id: eb82e883-b075-e9ce-e053-2995a90abb75
Set id: e336ff53-04e3-0b10-e053-2995a90ab314
Version: 2
Effective Time: 20221020
 
PROSAFEBIO