Shopko®

Shopko®
SPL v1
SPL
SPL Set ID 25b02f75-73d9-4590-b020-5fd488a05328
Route
TOPICAL
Published
Effective Date 2012-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.62 mL)
Inactive Ingredients
Water Propylene Glycol Aloe Vera Leaf Carbomer Interpolymer Type A (55000 Mpa.s) Polysorbate 20 Trolamine Vitamin A Palmitate Lactose Cellulose, Microcrystalline Hypromellose 2208 (100 Mpa.s) .alpha.-tocopherol Acetate Ultramarine Blue D&c Red No. 33 Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-06-21

Description

Ethyl Alcohol 62% w/w

Purpose

Anti-bacterial


Medication Information

Purpose

Anti-bacterial

Description

Ethyl Alcohol 62% w/w

Use
  • To decrease bacteria on the skin and clean hands.
  • Recommended for repeated use.
Warnings

For external use only.

Flammable, keep away from fire or flame.

Directions
  • Apply to hands until thoroughly wet.
  • Rub vigorously until dry.
  • Supervise children in the use of this product.
Questions?

1-800-FDA-1088

Discontinue Use

if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

Active Ingredient

Ethyl Alcohol 62% w/w

Do Not Get Into Eyes.

If contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children.

If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients (ocean Breeze)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, and Ultramarines

Inactive Ingredients (cherry Blossom)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5

Inactive Ingredients (dark Raspberry)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5

Package/label Principal Display Panel

bath·body·etc®

Ocean Breeze

anti-bacterial hand gel

1 fl. oz.

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp,

For ShopKo Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A

©2012 ShopKo Stores Operating Co., LLC

Ocean Breeze
Inactive Ingredients (red Pomegranate)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5

Inactive Ingredients (warm Vanilla Sugar)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5


Structured Label Content

Use
  • To decrease bacteria on the skin and clean hands.
  • Recommended for repeated use.
Purpose

Anti-bacterial

Warnings

For external use only.

Flammable, keep away from fire or flame.

Directions
  • Apply to hands until thoroughly wet.
  • Rub vigorously until dry.
  • Supervise children in the use of this product.
Questions? (QUESTIONS?)

1-800-FDA-1088

Discontinue Use (Discontinue use)

if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

Active Ingredient

Ethyl Alcohol 62% w/w

Do Not Get Into Eyes. (Do not get into eyes.)

If contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children. (Keep out of reach of children.)

If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients (ocean Breeze) (Inactive ingredients (Ocean Breeze))

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, and Ultramarines

Inactive Ingredients (cherry Blossom) (Inactive ingredients (Cherry Blossom))

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5

Inactive Ingredients (dark Raspberry) (Inactive ingredients (Dark Raspberry))

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5

Package/label Principal Display Panel (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL)

bath·body·etc®

Ocean Breeze

anti-bacterial hand gel

1 fl. oz.

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp,

For ShopKo Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A

©2012 ShopKo Stores Operating Co., LLC

Ocean Breeze
Inactive Ingredients (red Pomegranate) (Inactive ingredients (Red Pomegranate))

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5

Inactive Ingredients (warm Vanilla Sugar) (Inactive ingredients (Warm Vanilla Sugar))

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5


Advanced Ingredient Data


Raw Label Data

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