FUNDAMENTALS HANDLOTION- benzalkonium chloride lotion

Fundamentals Handlotion by

Drug Labeling and Warnings

Fundamentals Handlotion by is a Otc medication manufactured, distributed, or labeled by Clean Beauty Concepts. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
Lavendar 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.

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if

irritation or redness develop

Condition persists more than 72 hours

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

Lavendar 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: 76665-022-08

60 mL NDC: 76665-022-02

473 ml NDC: 76665-022-16

3785 ml NDC: 76665-022-01

INGREDIENTS AND APPEARANCE

FUNDAMENTALS HANDLOTION 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76665-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)	0.1 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.12 mL  in 100 mL
FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5)	0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	78.273 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	3.15 mL  in 100 mL
PETROLATUM (UNII: 4T6H12BN9U)	1.9 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	4.85 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.15 mL  in 100 mL
DIMETHICONE (UNII: 92RU3N3Y1O)	0.34 mL  in 100 mL
SODIUM ACRYLATE (UNII: 7C98FKB43H)	0.14 mL  in 100 mL
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)	0.145 mL  in 100 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	0.85 mL  in 100 mL
HEXYLENE GLYCOL (UNII: KEH0A3F75J)	0.14 mL  in 100 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	2.145 mL  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	1.852 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.125 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1 mL  in 100 mL
ISOHEXADECANE (UNII: 918X1OUF1E)	0.47 mL  in 100 mL
POLYSORBATE 60 (UNII: CAL22UVI4M)	0.74 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36)	0.2 mL  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.15 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.05 mL  in 100 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.2 mL  in 100 mL
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)	3.44 mL  in 100 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.14 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76665-022-08	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2020
2	NDC: 76665-022-01	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2020
3	NDC: 76665-022-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2020
4	NDC: 76665-022-16	473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - Clean Beauty Concepts (117491649)

Establishment
Name	Address	ID/FEI	Business Operations
Clean Beauty Concepts		117491649	manufacture(76665-022)