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NDC 63868-0115-07 Awaken by Quality Choice Foaming Hand Wash 1.3 mg/mL Details

Awaken by Quality Choice Foaming Hand Wash 1.3 mg/mL

Awaken by Quality Choice Foaming Hand Wash is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug MArketing Association Inc. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	63868-0115
Product ID	63868-115_bcf05d86-2aaa-4bff-98da-bc7192d12290
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	Awaken by Quality Choice Foaming Hand Wash
Proprietary Name Suffix	Spring Showers
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Chain Drug MArketing Association 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 63868-0115-07 (63868011507)

Pricing Information	N/A
NDC Package Code	63868-115-07
Billing NDC	63868011507
Package	222 mL in 1 BOTTLE, PLASTIC (63868-115-07)
Marketing Start Date	2016-08-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eb5938de-5ccf-4c68-8315-7cca38b0687c Details

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

helps eliminate bacterial on hands.

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, 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

Pump onto dry hands. Work into a rich foamy lather, rinse thoroughly and dry.

Other information

Store at room temperature.

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Fragrance (Parfum), Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Polysorbate 20, Sodium Citrate, Propylene Glycol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue1 (CI 42090), Ext. Violet 2 (CI 60730).

Questions or comments?

1-248-449-9300

Label Copy

INGREDIENTS AND APPEARANCE

AWAKEN BY QUALITY CHOICE FOAMING HAND WASH SPRING SHOWERS

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-115
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)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE SODIUM (UNII: MP1J8420LU)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-115-07	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/18/2016

Labeler - Chain Drug MArketing Association Inc (011920774)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(63868-115)

Revised: 8/2016

Document Id: bcf05d86-2aaa-4bff-98da-bc7192d12290

Set id: eb5938de-5ccf-4c68-8315-7cca38b0687c

Version: 1

Effective Time: 20160822