Bare Hands: Package Insert and Label Information

BARE HANDS- alcohol spray
Bell International Labroatories, Inc.

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.

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin.

recommended for repeated use

Warnings

For external use only

Flammable. Keep away from fire/flame.

When using this product do not use in or near the eyes. In case of eye contact, rinse thoroughly with water.

Stop use and ask a dotor if irritaion or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years of age should be supervised.

Directions

Dispense an adequate amount in your hands and rub hands together until dry. Does not require rinising.

Other information

Do not store above 104 F (40 C). May discolor certain fabrics or surfaces.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Water

3.4 fl oz bottle label

3.4 fl oz bottle label
(click image for full-size original)

BARE HANDS
hand sanitizer spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76150-239
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CHAMOMILE
WATER
ALOE VERA LEAF
GLYCERIN
CALENDULA OFFICINALIS FLOWER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76150-239-04 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/01/2020
Labeler — Bell International Labroatories, Inc. (967781555)

Revised: 05/2020 Bell International Labroatories, Inc.

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