BERNAL PREMIUM ALCOHOL WIPE- alcohol cloth

Bernal Premium Alcohol Wipe by

Drug Labeling and Warnings

Bernal Premium Alcohol Wipe by is a Otc medication manufactured, distributed, or labeled by Newport MFG LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

• to decrease bacteria on skin
• recommended for repeated use

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

• Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.
• Avoid contact with broken skin
• Do not inhale or ingest

STOP USE

• 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

• Wet hands thoroughly with product and allow drying without wiping.
• For children under 6, use only with adult supervision.
• Not recommended for use on infants.

Other information

• Store between 20-25C (67-77F)

Inactive ingredients

Aloe Barbadensis Leaf Extract, Citrus Limon Peel Oil, D-Limonene, Glycerin, Tocopherol Acetate (Vitamin E), Water

Package Label - Principal Display Panel

3 mL NDC: 80479-175-40

INGREDIENTS AND APPEARANCE

BERNAL PREMIUM ALCOHOL WIPE 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80479-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80479-175-15	15 in 1 BOX	10/20/2020
1		3 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 80479-175-99	100 in 1 BAG	10/20/2020
2		3 mL in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 80479-175-40	40 in 1 BOX	10/20/2020
3		3 mL in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 80479-175-01	3 mL in 1 POUCH; Type 0: Not a Combination Product	10/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/20/2020

Labeler - Newport MFG LLC (117654225)

Establishment
Name	Address	ID/FEI	Business Operations
Newport MFG LLC		117654225	manufacture(80479-175)