HAND SANITIZER 7- alcohol gel
Sangji Enterprise Co.,LTD Cheongwon Oriental Medical Cosmetic Branch

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.

----------

75695-0005_Hand Sanitizer 7

Active ingredient

Ethyl alcohol 70%

Purpose

Antimicrobial

Use

To decrease bacteria on skin that could cause disease

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children.

Other information

Store below 105°F (40°C)
May discolor certain fabrics or surfaces

Directions

Put enough product in you palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using HAND SANITIZER 7.

Inactive ingredients

Water, Gycerin, Triethyleneamine, Carbomer, Fragrance

Product Label

HAND SANITIZER 7
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75695-0005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75695-0005-1	29.57 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
2	NDC:75695-0005-2	59.14 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
3	NDC:75695-0005-3	88.72 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
4	NDC:75695-0005-4	118.29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
5	NDC:75695-0005-5	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/29/2020
6	NDC:75695-0005-6	3785.41 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/29/2020

Labeler - Sangji Enterprise Co.,LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)

Registrant - Sangji Enterprise Co.,LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)

Name	Address	ID/FEI	Business Operations
Establishment
Sangji Enterprise Co.,LTD Cheongwon Oriental Medical Cosmetic Branch		695625894	manufacture(75695-0005)