HQLA- hydroquinone cream
Private Label Skin Care

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.

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HQLA

Drug Facts

Active ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use • Lightens dark discolorations in skin such as: freckles, age and liver spots or pigment in the skin that may occur in the skin.

Warnings For external use only.

When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.

If pregnant or breast-feeding • Ask a physician before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions • Apply sparingly over face and neck, avoiding eye area. Can be used once a day at bedtime or as directed by physician.

Sunburn Alert • This product may increase your skins sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product.

Inactive Ingredients Water, Ethylhexyl Methoxycinnamate, Cetearyl Alcohol, Propylene Glycol, C12-15 Alkyl Benzoate, Cetyl Alcohol, Sorbitan Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Glycol Distearate, Potassium Cetyl Phosphate, Sodium Metabisulfite, Triticum Vulgare (Wheat) Germ Oil, Helianthus Annuus (Sunflower) Seed Oil, Xanthan Gum, Lactic Acid, Methylparaben, Allantoin, BHT, Imidazolidinyl Urea, Tetrasodium EDTA, Propylparaben

brand MD®

SKIN CARE

AGE DEFENSE

medical grade

√ Lightens overall complexion, corrects uneven skin tone

√ Reduces melanin formation

brandMD®

Chatsworth, CA 91311

www.brandMD.com

Toll Free: (877) 252-7546

Made in USA

Packaging

HQLADef

HQLA
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72957-004(NDC:39765-012)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
OCTINOXATE (UNII: 4Y5P7MUD51)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WHEAT GERM OIL (UNII: 14C97E680P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
XANTHAN GUM (UNII: TTV12P4NEE)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
IMIDUREA (UNII: M629807ATL)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72957-004-01	49 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/23/2020	09/10/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part358A	01/23/2020	09/10/2023

Labeler - Private Label Skin Care (116996962)

Name	Address	ID/FEI	Business Operations
Establishment
Private Label Skin Care		116996962	relabel(72957-004)

Revised: 1/2022

Document Id: 31c397b3-aa12-4da6-9cf4-0a893c999684

Set id: e365427e-639a-4bc8-9d5a-cb561f1df144

Version: 3

Effective Time: 20220120

Private Label Skin Care