Water Mountain Hand Sanitizer: Package Insert and Label Information

WATER MOUNTAIN HAND SANITIZER — alcohol gel
CUARTA DIMENSION USA, 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
For hand washing to decrease bacteria on the skin
Recommended for repeated use
Warnings
For external use only.
Avoid contact with broken skin.
Flammable. Keep away from heat and flame.
Keep out of reach of children.
Keep out of reach of children.
Children under 6 of age should be supervised when using this product.
Directions
Not recommanded for infants
Wet hands thoroughly with product and allow to dry without wiping
Children under 6 of age should be supervised when using this product.
Other Information
Do not store above 105 degrees F.
May discolor some fabrics. Inactive Ingredients Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Fragrance
image of bottle label
(click image for full-size original)
WATER MOUNTAIN HAND SANITIZER ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52979-8006
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
WATER
GLYCERIN
PROPYLENE GLYCOL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
TROLAMINE
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52979-8006-1 29 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 part333E 08/18/2012
Labeler — CUARTA DIMENSION USA, INC. (956733336)

Revised: 08/2012 CUARTA DIMENSION USA, INC.

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