SPOTFADE DARK SPOT WAND- hydroquinone lotion

Spotfade Dark Spot Wand by

Drug Labeling and Warnings

Spotfade Dark Spot Wand by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Fact Label

Active ingredient

Hydroquinone 2%

Purpose

Lightens dark spots

Warnings

For external use only

• do not use on damaged or broken skin.

When using this product

• when using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

• if rash occurs.

Keep out of reach of children.

• if swallowed, get medical help or contact a Poison Control Center right away.

Sunburn Alert

These products contain alpha hydroxy acids (AHAs) that 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 these products and for a week afterwards.

Children under 12 years of age: do not use unless directed by a doctor.

Directions

Adults: apply a small amount as thin layer on the affected area twice daily. Or use as directed by a doctor. If no improvement is seen after 3 months of treatment use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.

Inactive ingredients

Water, Alcohol Denat., Glycerin, Olive Oil Glycerth 8 Esters, Niacinamide, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Hexylresorcinol, Pentylene Glycol, Palmaria Palmata Extract, Sodium Sulfite, BHA, Retinol, Hexylene Glycol, Ethylhexylglycerin, Caprylyl Glycol, Maltodextrin, Denatonium Benzoate, t-Butyl Alcohol, Glycolic Acid, Polysorbate 80, Sorbitan Oleate, Disodium EDTA, Sodium Metabisulfite, Phenoxyethanol.

Questions or comments?

Within US 1-888-557-8164

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE BODY FIRM, LLC,
EL SEGUNDO, CA 90245

PRINCIPAL DISPLAY PANEL - 60 mL Tube Label

BODY FIRM®

Spot Fade®

Dark Spot
Correcting Wand
with 2% Hydroquinone

WITH TRULIGHT™
TECHNOLOGY

NIGHT

60mL | 2 FL.OZ.

INGREDIENTS AND APPEARANCE

SPOTFADE DARK SPOT WAND 
hydroquinone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Glycerin (UNII: PDC6A3C0OX)
OLIVE OIL GLYCERETH-8 ESTERS (UNII: 322K2STO13)
NIACINAMIDE (UNII: 25X51I8RD4)
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) (UNII: 1DXE3F3OZX)
Isohexadecane (UNII: 918X1OUF1E)
Hexylresorcinol (UNII: R9QTB5E82N)
Pentylene Glycol (UNII: 50C1307PZG)
Dulse (UNII: 7832HOY4ZQ)
Sodium Sulfite (UNII: VTK01UQK3G)
Retinol (UNII: G2SH0XKK91)
Hexylene Glycol (UNII: KEH0A3F75J)
Ethylhexylglycerin (UNII: 147D247K3P)
Caprylyl Glycol (UNII: 00YIU5438U)
Maltodextrin (UNII: 7CVR7L4A2D)
Laureth-23 (UNII: N72LMW566G)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Denatonium Benzoate (UNII: 4YK5Z54AT2)
Trideceth-6 Phosphate (UNII: NKT96BX1OC)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
Ceramide NP (UNII: 4370DF050B)
Tert-Butyl Alcohol (UNII: MD83SFE959)
4-METHOXYBENZOYLOXYACETIC ACID (UNII: A6VXV872O8)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Polysorbate 20 (UNII: 7T1F30V5YH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-037-95	1 in 1 CARTON	02/01/2020
1		20 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70605-037-22	1 in 1 CARTON	02/01/2020
2		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part358A	02/01/2020

Labeler - Guthy-Renker LLC (948861877)