Dosage and administration
Dispense lotion onto hands and rub into skin until absorbed Supervise children under 6 years of age when using this product to avoid swallowing
Fundamentals Handlotion
- Manufacturer
- Clean Beauty Concepts
- Effective date
- 2020-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:35:56
Label at a glance#
ProductFundamentals Handlotion
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections
Storage and handling
Store between 15-30°C (59-86°F) . • Avoid freezing and excessive heat above 40°C (104°F).
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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
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 SECTION
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 SECTION
Stop use and ask a doctor if
irritation or redness develop
Condition persists more than 72 hours
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
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: 76665-020-08
60 mL NDC: 76665-020-02
473 ml NDC: 76665-020-16
3785 ml NDC: 76665-020-01
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76665-020-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-018b-a426-e053-dadaa90af4c2 | b767b019-c89d-e29f-e053-2a95a90a2993 |
| 76665-020-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-018b-a426-e053-dadaa90af4c2 | b767b019-c89d-e29f-e053-2a95a90a2993 |
| 76665-020-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-018b-a426-e053-dadaa90af4c2 | b767b019-c89d-e29f-e053-2a95a90a2993 |
| 76665-020-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-018b-a426-e053-dadaa90af4c2 | b767b019-c89d-e29f-e053-2a95a90a2993 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76665-020-01 | Fundamentals Handlotion | 3785 mL in 1 BOTTLE, DISPENSING | LOTION | 3785 | 1 | |
| 76665-020-02 | Fundamentals Handlotion | 60 mL in 1 BOTTLE, DISPENSING | LOTION | 60 | 1 | |
| 76665-020-08 | Fundamentals Handlotion | 236 mL in 1 BOTTLE, DISPENSING | LOTION | 236 | 1 | |
| 76665-020-16 | Fundamentals Handlotion | 473 mL in 1 BOTTLE, DISPENSING | LOTION | 473 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Fundamentals Handlotion
- Benzalkonium Chloride
- VITAMIN A PALMITATE
- PHENOXYETHANOL
- FRAGRANCE CLEAN ORC0600327
- WATER
- PROPYLENE GLYCOL
- PETROLATUM
- GLYCERIN
- BENZALKONIUM
- ALOE VERA LEAF
- DIMETHICONE
- SODIUM ACRYLATE
- SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
- POLYSORBATE 80
- HEXYLENE GLYCOL
- STEARYL ALCOHOL
- CETYL ALCOHOL
- .ALPHA.-TOCOPHEROL ACETATE
- ISOHEXADECANE
- POLYSORBATE 60
- CARBOMER 1342
- XANTHAN GUM
- SODIUM HYDROXIDE
- ETHYLHEXYLGLYCERIN
- C12-20 ALKYL BENZOATE
- CAPRYLYL GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76665-020 | 76665-020-08, 76665-020-01, 76665-020-02, 76665-020-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b767b05a-9e20-4a4d-e053-2995a90af65b | b767b019-c89d-e29f-e053-2a95a90a2993 | 2020-12-26 | Warnings | b767b05a-9e20-4a4d-e053-2995a90af65b b767b019-c89d-e29f-e053-2a95a90a2993 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.