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NDC 62041-0260-01 AAPE Hair Ampoule 0.03 g/6mL Details

AAPE Hair Ampoule 0.03 g/6mL

AAPE Hair Ampoule is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by PROSTEMICS Co., Ltd.. The primary component is PANTHENOL.

Product Information

NDC	62041-0260
Product ID	62041-260_6c7ecff6-bee9-489a-a048-2b39a5c03d11
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	AAPE Hair Ampoule
Proprietary Name Suffix	n/a
Non-Proprietary Name	Panthenol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.03
Active Ingredient Units	g/6mL
Substance Name	PANTHENOL
Labeler Name	PROSTEMICS Co., Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 62041-0260-01 (62041026001)

Pricing Information	N/A
NDC Package Code	62041-260-01
Billing NDC	62041026001
Package	6 mL in 1 CONTAINER (62041-260-01)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 59b8267a-7384-43da-8bc9-5b3163855c06 Details

ACTIVE INGREDIENT

Active ingredients: Panthenol 0.5%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Alcohol, Propylene Glycol, Glycerin, Lactic Acid, Hydroxyacetophenone, Propanediol, Polyquaternium-7, Niacinamide, Polysorbate 20, Butylene Glycol, Caprylhydroxamic Acid, Disodium EDTA, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Sophora, Angustifolia Root Extract, Angelica Gigas Root Extract, Cnidium Officinale Root Extract, Glycine Max (Soybean) Seed Extract, Polygonum Multiflorum Root Extract, 1,2-Hexanediol, Sodium Benzoate

PURPOSE

Purpose: Hair elasticity

WARNINGS

Warnings:

For external use only

1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product

2. Do not apply to open wounds.

3. Avoid contact with eyes.

Storage and handling

4. Keep in the refrigerator at 2-6°C.

5. Keep out of reach of children.

6. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Improves effects of hair elasticity.

Directions

Directions:

Gently mix with AAPE powder to dissolve the mixture.

Take proper amount and gently apply onto the scalp.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AAPE HAIR AMPOULE

panthenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62041-260
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	Panthenol	0.03 g in 6 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62041-260-01	6 mL in 1 CONTAINER; Type 0: Not a Combination Product	08/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/01/2019

Labeler - PROSTEMICS Co., Ltd. (689605919)

Registrant - PROSTEMICS Co., Ltd. (689605919)

Name	Address	ID/FEI	Business Operations
Establishment
Prostemics Co., Ltd. Factory		695687674	manufacture(62041-260)

Revised: 8/2019

Document Id: 6c7ecff6-bee9-489a-a048-2b39a5c03d11

Set id: 59b8267a-7384-43da-8bc9-5b3163855c06

Version: 1

Effective Time: 20190826