SEA AND SKI HAND SANITIZER GEL- ethyl alcohol gel
Cross Brands Contract Filling

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.

----------

Sea & Ski Advance Hand Sanitizer Gel 16oz

Active Ingredient

Active Ingredient Ethyl Alcohol 62%

Purpose

Purpose Section Antiseptic

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Warnings

For external use only: Hands

Flammable, keep away from fire or flame

When Using

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest

Stop use

Stop Use and ask a doctor if irritation or redness develops condition persists for more than 72 hours

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

Directions wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Other information

Other information do not store above 105°F may discolor some fabrics harmful to wood finishes and plastics

Inactive Ingredients

Inactive ingredients

acrylates copolymer*, aloe barbadensis leaf extract carbomer*, tocopheryl acetate (vitamin E), triethanolamine, water

*contains one or more of these ingredients

Package Label Principal Display Panel

Front Label

SEA AND SKI HAND SANITIZER GEL
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73440-2159
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	258.07 g in 416.24 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	131.55 g in 416.24 g

Product Characteristics
Color	white (Clear viscous Gel)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73440-2159-1	416.24 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/10/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/10/2021

Labeler - Cross Brands Contract Filling (116950257)

Name	Address	ID/FEI	Business Operations
Establishment
Cross Brands Contract Filling		116950257	label(73440-2159) , manufacture(73440-2159) , pack(73440-2159)

Revised: 2/2021

Document Id: bafeadef-d899-335c-e053-2a95a90ab0a3

Set id: bafeadef-d898-335c-e053-2a95a90ab0a3

Version: 1

Effective Time: 20210210

Cross Brands Contract Filling