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NDC 63148-0842-08 Giant Eagle Coconut Water Foaming 1.3 mg/mL Details

Giant Eagle Coconut Water Foaming 1.3 mg/mL

Giant Eagle Coconut Water Foaming is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Apollo Health and Beauty Care Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	63148-0842
Product ID	63148-842_ffd9ef69-ec59-4313-8218-b453b5aa7c7e
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	Giant Eagle Coconut Water Foaming
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Apollo Health and Beauty Care Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2022-12-31

Package

Package Images

NDC 63148-0842-08 (63148084208)

Pricing Information	N/A
NDC Package Code	63148-842-08
Billing NDC	63148084208
Package	222 mL in 1 BOTTLE, PLASTIC (63148-842-08)
Marketing Start Date	2017-05-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4cba6960-9208-411e-ad58-f602f3461106 Details

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

helps eliminate bacteria on hands.

Warnings

For external use only.

When using this product

avoid contact with eyes
in case of contact, rinse thoroughly with water

Stop use and ask a doctor if

irritation or redness develops and lasts

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

apply onto dry hands
lather and rinse thoroughly

Other information

store at room temperature

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Label Copy

INGREDIENTS AND APPEARANCE

GIANT EAGLE COCONUT WATER FOAMING

benalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63148-842
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT (UNII: 3RT3536DHY)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SULISOBENZONE (UNII: 1W6L629B4K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63148-842-08	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/23/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/23/2017

Labeler - Apollo Health and Beauty Care Inc. (201901209)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-842)

Revised: 5/2017

Document Id: ffd9ef69-ec59-4313-8218-b453b5aa7c7e

Set id: 4cba6960-9208-411e-ad58-f602f3461106

Version: 1

Effective Time: 20170524