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NDC 59779-0778-08 CVS Health Prebiotic Sanitizer 650 mg/mL Details

CVS Health Prebiotic Sanitizer 650 mg/mL

CVS Health Prebiotic Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is ALCOHOL.

Product Information

NDC	59779-0778
Product ID	59779-778_d967044a-4919-49d4-9ef2-ed5aff75083b
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	CVS Health Prebiotic Sanitizer
Proprietary Name Suffix	n/a
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	CVS Pharmacy
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 59779-0778-08 (59779077808)

Pricing Information	N/A
NDC Package Code	59779-778-08
Billing NDC	59779077808
Package	237 mL in 1 BOTTLE, PLASTIC (59779-778-08)
Marketing Start Date	2017-02-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL de3ee58d-48c7-4a23-b7bd-f0688192a709 Details

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin.

Warnings

For external use only: hands

Flammable. Keep away from fire or flame.

When using this product

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops.
condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

put enough product in your palm to cover hands and rub hand together until dry.
for children under 6, use only under adult supervision
not recommended for infants.

Other information

store at a temperature below 110F (43C).
may discolor some fabrics.

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharaide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

Label Copy

INGREDIENTS AND APPEARANCE

CVS HEALTH PREBIOTIC SANITIZER

ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-778
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)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER 934 (UNII: Z135WT9208)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-778-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/21/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/21/2017

Labeler - CVS Pharmacy (062312574)

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

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(59779-778)

Revised: 2/2017

Document Id: d967044a-4919-49d4-9ef2-ed5aff75083b

Set id: de3ee58d-48c7-4a23-b7bd-f0688192a709

Version: 1

Effective Time: 20170222