OTC Medication Information: Colemerg Sanitizing Wipes

COLEMERG SANITIZING WIPES- alcohol cloth
COLEMERG PRODUCTS LLC

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.

Drug Facts

Active Ingredients

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

  • For hand and skin sanitizing.
  • When water, soap and towel are not available.
  • Recommended for repeated use.

WARNINGS

  • For external use only.
  • Flammable, keep away from fire or flame.

When Using This Product:

  • Do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.
  • Use wipes only on unbroken intact skin.
  • If you have sensitive skin or certain allergies, check the list of ingredients on the label before using wipes.
  • Do not ingest.

Stop use and ask a doctor:

If skin irritation or redness develops.

Keep out of reach of children.

  • Children under 6 years of age use only under adult supervision.
  • If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions:

Not recommended for infants.

Other Information:

  • Store below 110 °F (43 °C)
  • May discolor certain fabrics or surfaces.

Inactive Ingredients:

Aqua/Water, Glycerin, Propylene Glycol, Fragrance, Sodium PCA, Disodium EDTA.

Package Labeling:

label
(click image for full-size original)

COLEMERG SANITIZING WIPES
alcohol cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80171-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.75 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
SODIUM PYRROLIDONE CARBOXYLATE
EDETATE DISODIUM ANHYDROUS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80171-003-00 80 PATCH in 1 CANISTER contains a PATCH
1 2.9 mL in 1 PATCH This package is contained within the CANISTER (80171-003-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/20/2020
Labeler — COLEMERG PRODUCTS LLC (117617946)

Revised: 11/2020 COLEMERG PRODUCTS LLC

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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