WET WIPES SANITIZER- alcohol swab
LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN

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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Antibacterial

For external use only.Keep out of the eyes. In case of eye contact, rinse with water.If irritation develps discontinue use and consult a doctor if irritation persists more than 72 hours. If swallowed, seek medical attention or contact a Poison Control Center.

Alcohol Denat (Ethanol) ,Glycerin, Melaleuca Alternifolia Leaf Extract, Hypericum Perforatum Extract, Chlorhexidine Gluconate , Aqua

% 80 Alcohol Denat (Ethanol)

ecreases bacteria on skin. recommended for repeated use

Keep out of the reach of children, except with adult supervision.

ake wipe and rub thoroughly over all surfaces of both hands.Rrub hands together briskly to dry·dispose of wipe. For children under 2 years ask a doctor before use.

creamol ingredient

WET WIPES SANITIZER
alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77892-0004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
HYPERICUM PERFORATUM LEAF (UNII: DOC7OB843Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77892-0004-1	2 g in 1 POUCH; Type 0: Not a Combination Product	08/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/31/2020

Labeler - LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN (502952094)

Name	Address	ID/FEI	Business Operations
Establishment
LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN		502952094	manufacture(77892-0004)