Instant Hand Sanitizer

INSTANT HAND SANITIZER- ethyl alcohol gel
China Ningbo Shangge Cosmetic Technology Corp.

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

Ethyl Alcohol 62.0%

Antimicrobial

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

Directions

wet hands thoroughly with product
briskly rub hands together until dry
supervise children under 6 years in the use of this product

Use:

for handwashing to decrease bacteria on the skin
recommended for repeated use

Warnings:

For external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Inactive Ingredients: water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate (Vitamin E), fd&c blue no. 1, fd&c yellow no. 5.

INSTANT HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58503-097
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58503-097-01	53 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/25/2017

Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(58503-097)