OTC Medication Information: P.A.W.S. Hand Sanitizer Bottle

P.A.W.S. HAND SANITIZER BOTTLE- alcohol spray
Safetec

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 66.5%

Purpose

Antiseptic

Uses

  • for handwashing to decrease bacteria on skin whenever soap and water is not readily available.

Warnings

For external use only. Flammable, keep away from flame.

Do not use in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask a doctor if

  • irritation or redness develops and 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 hands & wrists thoroughly with product and allow to dry without wiping
  • children under 6 years of age should be supervised when using this product

Inactive ingredients

aloe vera, fragrance, purified water, triethanolamine

Principal Display Panel — 118 mL Bottle Label

Safetec

A.B.H.C. ™ MEETS CDC HANDWASHING RECOMMENDATIONS

instant
Hand
Sanitizer Spray

Kills 99.99% of Germs

Enriched with Aloe Vera

Fresh

4 fl. oz. (118.3 ml)

Principal Display Panel -- 118 mL Bottle Label
(click image for full-size original)
P.A.W.S. HAND SANITIZER BOTTLE
alcohol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-3113
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 66.5 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
aloe vera leaf
water
trolamine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61010-3113-0 59 mL in 1 BOTTLE, SPRAY None
2 NDC:61010-3113-1 118 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/07/2021
Labeler — Safetec (874965262)
Establishment
Name Address ID/FEI Operations
Safetec 874965262 MANUFACTURE (61010-3113)

Revised: 08/2021 Safetec

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.

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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