APPLE BLOSSOM ANTI-BACTERIAL HAND SANITIZER- alcohol gel
Kingsbridge International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Apple Blossom Anti-bacterial Hand Sanitizer

Active Ingredient

Ethyl Alcohol 65%

Antiseptic

Uses

Hand sanitizer to decrease bacteria on the skin.

Warnings

For external use only

When using this

product avoid contact with eyes. In case of contact, flush eyes thoroughly with water.

Flammable.

Keep away from heat or flame.

Stop and ask doctor

if irritation or redness develop.

Keep out of reach of children.

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

Directions

Wet hand thoroughly with product and allow to dry without wiping.
Children under 6 years of age should be supervised when using this product.

Other information

Do not store above 104 F(40 C)
May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Phenoxyethanol, Fragrance, Carbomer, Sodium Hydroxide, DMDM Hydantoin, FD&C Blue No.1, FD&C Yellow No. 5

Package Label

label

APPLE BLOSSOM ANTI-BACTERIAL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69124-006
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69124-006-29	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2014	09/17/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/16/2014	09/17/2014

Labeler - Kingsbridge International, Inc. (030002115)

Revised: 1/2017

Document Id: 468e7df1-faa1-5f64-e054-00144ff8d46c

Set id: d0999e06-cd98-4d88-92bc-c582444d837b

Version: 2

Effective Time: 20170120

Kingsbridge International, Inc.