BROMPTON AND LANGLEY COCONUT WATER AND HABISCUS HAND SANITIZER COCONUT WATER AND HABISCUS- alcohol denat gel
Cita International Limited

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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Active Ingredient

Alcohol 62%

Purpose: Antiseptic

Use

To decrease bacteria on the skin that could cause disease.

Keep out of reach of children.

Warnings

Keep away from flame or fire
for external use only-hands.
keep out of eyes.
stop use and ask a Doctor if irritation or redness persists for more than 72 hours
do not inhale or ingest. if swallowed, get medical help or contact a poison control center right away.

Directions

spray a thumb size amount into hands.
rub hands together gently making sure to cover all areas in between fingers
let hands air dry

Inactive Ingredients

water (aqua/eau), glycerin, propylen glycol, Isopropyl alcohol, phenoxythenol, acrylates,

lauryl glycol ether, carbomer, Vitamin E, fragrance (parfum).

Brompton and Langley
Coconut Water and Habiscus Scentend Hand Sanitizer
15mL

LABEL

BROMPTON AND LANGLEY COCONUT WATER AND HABISCUS HAND SANITIZER COCONUT WATER AND HABISCUS
alcohol denat gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70805-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.26 g in 26 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHOXY PEG-40 (UNII: 6AXS45P1QU)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color		Score
Shape		Size
Flavor	COCONUT (Coconut Water and Habiscus)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70805-003-01	15 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/12/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/03/2016

Labeler - Cita International Limited (665926739)

Name	Address	ID/FEI	Business Operations
Establishment
Cita International Limited		665926739	manufacture(70805-003)