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NDC 81745-0301-01 ATOA 1; .5; 1; 4; 1; 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Details

ATOA 1; .5; 1; 4; 1; 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL

ATOA is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by PROSAFEBIO. The primary component is ANGELICA GIGAS ROOT; ASIAN GINSENG; OPUNTIA HUMIFUSA WHOLE; RICE BRAN; SCUTELLARIA BAICALENSIS ROOT; SOPHORA FLAVESCENS ROOT.

Product Information

NDC	81745-0301
Product ID	81745-301_eb82e883-b075-e9ce-e053-2995a90abb75
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ATOA
Proprietary Name Suffix	n/a
Non-Proprietary Name	rice bran extract
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1; .5; 1; 4; 1; 1
Active Ingredient Units	g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
Substance Name	ANGELICA GIGAS ROOT; ASIAN GINSENG; OPUNTIA HUMIFUSA WHOLE; RICE BRAN; SCUTELLARIA BAICALENSIS ROOT; SOPHORA FLAVESCENS ROOT
Labeler Name	PROSAFEBIO
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 81745-0301-01 (81745030101)

Pricing Information	N/A
NDC Package Code	81745-301-01
Billing NDC	81745030101
Package	300 mL in 1 BOTTLE, PLASTIC (81745-301-01)
Marketing Start Date	2022-07-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e336ff53-04e3-0b10-e053-2995a90ab314 Details

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

INGREDIENTS AND APPEARANCE

ATOA

rice bran extract cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81745-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RICE BRAN (UNII: R60QEP13IC) (RICE BRAN - UNII:R60QEP13IC)	RICE BRAN	4 g in 100 mL
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K)	SOPHORA FLAVESCENS ROOT	1 g in 100 mL
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) (SCUTELLARIA BAICALENSIS ROOT - UNII:7J95K7ID2S)	SCUTELLARIA BAICALENSIS ROOT	1 g in 100 mL
OPUNTIA HUMIFUSA WHOLE (UNII: 6E9O5V4SS5) (OPUNTIA HUMIFUSA WHOLE - UNII:6E9O5V4SS5)	OPUNTIA HUMIFUSA WHOLE	1 g in 100 mL
ANGELICA GIGAS ROOT (UNII: 32766B2FHX) (ANGELICA GIGAS ROOT - UNII:32766B2FHX)	ANGELICA GIGAS ROOT	1 g in 100 mL
ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI)	ASIAN GINSENG	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81745-301-01	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/07/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/07/2022

Labeler - PROSAFEBIO (695501710)

Registrant - PROSAFEBIO (695501710)

Name	Address	ID/FEI	Business Operations
Establishment
PROSAFEBIO		695501710	manufacture(81745-301)

Revised: 10/2022

Document Id: eb82e883-b075-e9ce-e053-2995a90abb75

Set id: e336ff53-04e3-0b10-e053-2995a90ab314

Version: 2

Effective Time: 20221020

Search by Drug Name or NDC

NDC 81745-0301-01 ATOA 1; .5; 1; 4; 1; 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Details

ATOA 1; .5; 1; 4; 1; 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL

Product Information

Package

Package Images

NDC 81745-0301-01 (81745030101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e336ff53-04e3-0b10-e053-2995a90ab314 Details

purpose

Use

Warnings

Warnings

Warnings

Warnings

Warnings

Directions

active ingredient

Inactive Ingredients

Other information

Question? Comments?

ATOA

INGREDIENTS AND APPEARANCE

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