FDA Label for Fundamentals Handlotion
View Indications, Usage & Precautions
Fundamentals Handlotion Product Label
The following document was submitted to the FDA by the labeler of this product Clean Beauty Concepts. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
The hand lotion is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:
Benzalkonium chloride
Water (aqua)
Glycerin
C12-15 Alkyl benzoate
propylene glycol
stearyl alcohol
cetyl alcohol
Petrolatum
ocimum basilicum (basil) oil
aloe barbadensis (aloe vera) leaf juice
retinyl palmitate (vitamin A)
tocopheryl acetate (vitamin E)
dimethicone
sodium acrylate
acryloyldimethyltaurate copolymer
polysorbate 80
isohexadecane
polysorbate 60
acrylates/C10 30 Alkyl acrylate crosspolymer
hexylene glycol
xanthan gum
sodium hydroxide
phenoxyethanol
caprylyl glycol
ethylhexylglycerin
fragrance (parfum)
Active Ingredient(S)
Benzalkonium chloride 0.13% v/v. Purpose: Antimicrobial
Purpose
Antimicrobial
Use
To decrease bacteria on skin
Recommended for repeat use
Warnings
For external use only.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if
irritation or redness develop
Condition persists more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Dispense lotion onto hands and rub into skin until absorbed
Supervise children under 6 years of age when using this product to avoid swallowing
Other Information
- Store between 15-30°C (59-86°F) .
• Avoid freezing and excessive heat above 40°C (104°F).
Inactive Ingredients
Water (aqua)
Glycerin
C12-15 Alkyl benzoate
propylene glycol
stearyl alcohol
cetyl alcohol
Petrolatum
ocimum basilicum (basil) oil
aloe barbadensis (aloe vera) leaf juice
retinyl palmitate (vitamin A)
tocopheryl acetate (vitamin E)
dimethicone
sodium acrylate
acryloyldimethyltaurate copolymer
polysorbate 80
isohexadecane
polysorbate 60
acrylates/C10 30 Alkyl acrylate crosspolymer
hexylene glycol
xanthan gum
sodium hydroxide
phenoxyethanol
caprylyl glycol
ethylhexylglycerin
fragrance (parfum)
Do Not Use
Do not Use
in children less than 2 months old
on open skin wounds
Package Label - Principal Display Panel
236 mL NDC: 76665-025-08
60 mL NDC: 76665-025-02
NDC: 76665-025-16
NDC: 76665-025-01
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