OTC Medication Information: ACORE Peppermint Hand Sanitizer Boys

ACORE PEPPERMINT HAND SANITIZER BOYS- alcohol gel
Gold Orient International Limited

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

Alcohol Denat. 62%

Purpose

Antiseptic

Use

Use for hand-washing to decrease bacteria on the skin, only when water it not available.

Warnings

For external use only. Flammable, keep away from fire and flames.

When using this product

Do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

If irritation and redness develop.

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 to dry without wiping

Other information

Store at 68 to 77F (20-25C)

Do not store above 110F (43C)

You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536

Inactive ingredients

Water,

Glycerin,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Fragrance,

Polysorbate 20,

Sodium Hydroxide,

Blue 1,

Yellow 5

label

Label
(click image for full-size original)

ACORE PEPPERMINT HAND SANITIZER BOYS
alcohol denat. gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51522-044
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
FD&C BLUE NO. 1
POLYSORBATE 20
FD&C YELLOW NO. 5
GLYCERIN
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51522-044-01 1 BOTTLE, PLASTIC in 1 CASE contains a BOTTLE, PLASTIC
1 30 mL in 1 BOTTLE, PLASTIC This package is contained within the CASE (51522-044-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/31/2020
Labeler — Gold Orient International Limited (679905914)
Establishment
Name Address ID/FEI Operations
Gold Orient International Limited 679905914 manufacture (51522-044)

Revised: 07/2020 Gold Orient International Limited

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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