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NDC 49738-0408-02 Smart Sense Hand Sanitizer Cotton Breeze 650 mg/mL Details

Smart Sense Hand Sanitizer Cotton Breeze 650 mg/mL

Smart Sense Hand Sanitizer Cotton Breeze is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Kmart Corporation. The primary component is ALCOHOL.

Product Information

NDC	49738-0408
Product ID	49738-408_0add8e2a-d0d8-4655-bc18-3ec5d3de4698
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	Smart Sense Hand Sanitizer Cotton Breeze
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	Kmart Corporation
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 49738-0408-02 (49738040802)

Pricing Information	N/A
NDC Package Code	49738-408-02
Billing NDC	49738040802
Package	59 mL in 1 BOTTLE, PLASTIC (49738-408-02)
Marketing Start Date	2016-10-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3165d26b-3e4b-403d-9977-36dec01ff969 Details

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from flame or fire.

When using this product

avoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

Apply a small amount to your palm and rub hands together briskly until dry. Children 6 years of age and under should be supervised when using this product.

Other information

Store at a temperature below 110°F (43°C).

Inactive ingredients

Water (Aqua), Propylene Glycol, Fragrance (Parfum), Benzophenone-4, Carbomer, Glycerin, Tocopheryl Acetate, Aminomethyl Propanol, Isopropyl Myristate, Blue 1 (CI 42090), Red 33 (CI 17200).

Questions or comments?

1-866-695-3030

Label Copy

INGREDIENTS AND APPEARANCE

SMART SENSE HAND SANITIZER COTTON BREEZE

ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49738-408
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SULISOBENZONE (UNII: 1W6L629B4K)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
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:49738-408-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/03/2016

Labeler - Kmart Corporation (008965873)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(49738-408)

Revised: 10/2016

Document Id: 0add8e2a-d0d8-4655-bc18-3ec5d3de4698

Set id: 3165d26b-3e4b-403d-9977-36dec01ff969

Version: 1

Effective Time: 20161004