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NDC 63868-0476-08 Awaken by Quality Choice Hand Sanitizer 650 mg/mL Details

Awaken by Quality Choice Hand Sanitizer 650 mg/mL

Awaken by Quality Choice Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc. The primary component is ALCOHOL.

Product Information

NDC	63868-0476
Product ID	63868-476_4cd7193b-be70-4a32-82f0-249793f231eb
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 Hand Sanitizer
Proprietary Name Suffix	Vanilla Crm and Apple Blossom
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	650
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
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 63868-0476-08 (63868047608)

Pricing Information	N/A
NDC Package Code	63868-476-08
Billing NDC	63868047608
Package	259 mL in 1 BOTTLE, PLASTIC (63868-476-08)
Marketing Start Date	2016-08-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 62b1c1d9-baca-4818-b983-3be511b55ad1 Details

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

helps eliminate bacteria on hands.

Warnings

For external use only.

Flammable
Keep away from source of heat or fire

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

Put enough product in your palm to cover hands and rub hand together until dry. Children under 6 years should be supervised when using this product.

Other information

store at a temperature below 110°F (43°C)
may discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Vanilla Planifolia Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Aloe Barbadensis Leaf Juice, Mannitol, Cellulose, Tocopheryl Acetate, Retinyl Palmitate, Hydroxypropyl Methylcellulose, Panthenol, Iron Oxides (CI 77491), Titanium Dioxide (CI 77891), Red 33 (CI 17200).

Questions or comments?

1-284-449-9300

Label Copy

INGREDIENTS AND APPEARANCE

AWAKEN BY QUALITY CHOICE HAND SANITIZER VANILLA CRM AND APPLE BLOSSOM

ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-476
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	650 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
VANILLA (UNII: Q74T35078H)
APPLE (UNII: B423VGH5S9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PANTHENOL (UNII: WV9CM0O67Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-476-08	259 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(63868-476)

Revised: 8/2016

Document Id: 4cd7193b-be70-4a32-82f0-249793f231eb

Set id: 62b1c1d9-baca-4818-b983-3be511b55ad1

Version: 1

Effective Time: 20160822