PURE CARNATION- alcohol liquid
Eng Kah Enterprise Sdn.Bhd

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 77% v/v.

Purpose

Antiseptic

Use[s]

Health care personnel hand rub used to eliminate infectious germs that can cause diseases immediately and effectively.

Warnings

For external use only...

Flammable. Keep away from heat or flame...

Do not use:

In children less than 2 years old.
On open skin wound.

When using this product keep out eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store in cool, dry place (below 300C) and protect from heat. Must put in upright position.

Inactive ingredients

Water, Glycerin, Fragrance.

Package Label - Principal Display Panel

Label_1 Label_2

PURE CARNATION
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42498-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	77 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42498-002-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
2	NDC:42498-002-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
3	NDC:42498-002-03	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
4	NDC:42498-002-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
5	NDC:42498-002-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
6	NDC:42498-002-06	600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
7	NDC:42498-002-07	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
8	NDC:42498-002-08	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
9	NDC:42498-002-09	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
10	NDC:42498-002-10	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
11	NDC:42498-002-11	25000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/08/2020

Labeler - Eng Kah Enterprise Sdn.Bhd (652389594)

Name	Address	ID/FEI	Business Operations
Establishment
Eng Kah Enterprise Sdn.Bhd.		652389594	manufacture(42498-002)