WINTER APPLE- hand sanitizer gel

Winter Apple by

Drug Labeling and Warnings

Winter Apple by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Inc, Vi-Jon, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 62%

Purpose

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 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 and ask a doctor if

• irritation or redness develops
• condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

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

Other information

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

Inactive ingredients

water, glycerin, carbomer, fragrance, red 40, red 33

SPL UNCLASSIFIED SECTION

*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds

DISTRIBUTED BY

MIEJER DSTRIBUTION, INC

GRAND RAPIDS, MI 49544

www.meijer.com

Questions 1-999-593-0593

principal display panel

meijer

Hand Sanitizer

Winter Apple

Kills 99.99% of germs

2 fl oz (59 mL)

548.000/548AA

INGREDIENTS AND APPEARANCE

WINTER APPLE 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-119-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2016
2	NDC: 41250-119-10	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2016
3	NDC: 41250-119-06	33 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2016
4	NDC: 41250-119-34	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/24/2016
5	NDC: 41250-119-38	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/24/2016
6	NDC: 41250-119-32	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/24/2016

Labeler - Meijer Distribution, Inc (006959555)

Registrant - Vi-Jon, Inc. (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		790752542	manufacture(41250-119)