HAND SANITIZER- ethyl alcohol gel
Sunshine Tape Products LLC

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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HAND SANITIZER GEL

ACTIVE INGREDIENT

ETHYL ALCOHOL 62%

PURPOSE

ANTISEPTIC

USES

Helps reduce bacteria on the skin. Recommended for repeated use.

WARNINGS

For external use only. Flammable. Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact flush thoroughly with water. Avoid contact with open skin. Stop use and ask doctor if irritation or rash develops.

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

DIRECTIONS

Dispense enough product onto hands and rub together quickly until dry. Use as needed. Children under 6 years of age, use only under adult supervision.

INACTIVE INGREDIENTS

Purified water, Propylene Glycol, Glycerin, Carbomer, Triethanolamine, Tocopherol Acetate, Coconut Oil, Aloe Vera gel, Fragrance

01b LBL_Sunshine_Hand Sanitizer

HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74598-111
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
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCONUT OIL (UNII: Q9L0O73W7L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74598-111-18	238 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2020
2	NDC:74598-111-14	118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	04/03/2020
3	NDC:74598-111-16	476 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2020
4	NDC:74598-111-11	3785 mL in 1 JUG; Type 0: Not a Combination Product	04/03/2020
5	NDC:74598-111-12	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/03/2020

Labeler - Sunshine Tape Products LLC (080833035)