SIMIKA- sanitizing gel gel

SIMIKA by

Drug Labeling and Warnings

SIMIKA by is a Otc medication manufactured, distributed, or labeled by Guangzhou Ouzhuang Biological Technology Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of 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.

STOP USE

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

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 between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

aloe barbadensis leaf extract, fragrant Orchid, propylene glycol, carbomer, triethanolamine, purified water

Package Label - Principal Display Panel

500 mL NDC: 77598-133-05

INGREDIENTS AND APPEARANCE

SIMIKA 
sanitizing gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77598-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GYMNADENIA CONOPSEA WHOLE (UNII: TF911C619B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77598-133-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
2	NDC: 77598-133-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
3	NDC: 77598-133-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
4	NDC: 77598-133-04	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
5	NDC: 77598-133-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
6	NDC: 77598-133-06	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
7	NDC: 77598-133-07	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
8	NDC: 77598-133-08	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
9	NDC: 77598-133-10	30 mL in 1 PACKET; Type 0: Not a Combination Product	05/15/2020
10	NDC: 77598-133-11	10 mL in 1 PACKET; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2020

Labeler - Guangzhou Ouzhuang Biological Technology Co Ltd (418234821)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Ouzhuang Biological Technology Co Ltd		418234821	manufacture(77598-133)