TotalDry Hand Sanitizer: Package Insert and Label Information

TOTALDRY HAND SANITIZER- alcohol solution
Secure Personal Care 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.

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

USES

  • Hand sanitizer helps reduce bacteria on the skin.
  • Can be used repeatedly.

WARNINGS

Flammable. Keep away from fire or flames.

For external use only.

  • Avoid contact with or near eyes when using this product. In case of contact, rinse eyes thoroughly with water.

If irritation or rash appears, stop use and contact a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a
Poison Control Center right away.

DIRECTIONS

  • Place product in palm of hand.
  • Rub hands together until dry.
  • Supervise children under 6 years of age when using product.

INACTIVE INGREDIENTS

Water, Carbomer, Aloe Barbadensis Leaf Juice,
Triethanolamine, Glycerin, Tocopheryl Acetate.

STORAGE

Store below 110°F (43°C).

Label

Label
(click image for full-size original)

TOTALDRY HAND SANITIZER
alcohol hand sanitizer solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73703-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL .7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ALOE VERA LEAF
TROLAMINE
GLYCERIN
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73703-001-11 3785 mL in 1 BOTTLE None
2 NDC:73703-001-01 118 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 05/15/2020
Labeler — Secure Personal Care Products LLC (022013246)
Establishment
Name Address ID/FEI Operations
Secure Personal Care Products LLC 022013246 label (73703-001)
Establishment
Name Address ID/FEI Operations
Westwood Laboratories, Inc 832280635 manufacture (73703-001)

Revised: 05/2020 Secure Personal Care Products LLC

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