NADINOLA SKIN FADEEXTRA- hydroquinone, octisalate cream
J. Strickland & Co.

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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Nadinola Skin Fade Cream Extra

Active Ingredients:

Hydroquinone, 3%, Octisalate, 3%

Purpose

Skin Lightener

Sunscreen

Uses:

Gradually fades areas of skin discoloration such as

age spots
freckles
liver spots
dark areas that can occur while using oral contraceptives.

Warnings

For External Use Only.

Do not use

on inflamed or brocken skin
to prevent of sunburn
if product is tan or brown

When using this product

mild irration may occur a
avoid contact with eyes. If contact occurs, Rinse With water.
avoid unnecessary sun exposure and use a sunscreen or protective clothing

Stop use and ask a doctor if

a gradual blue-black darkening of the skin occurs
irritation becomes severe
no improvement is seen after 3 months

If pregnant or breast-feeding

consult a health professional before use.

Keep out of reach of children

Directions:

If skin is sensitive, test on a small area inside elbow overnight before use.
Adults and children 12 years and older, apply a thin layer to affected area twice daily, or as directed by a doctor.
If going outside, use a sunscreen or wear protective clothing.
Children under 12 years of age, ask a doctor before use.

Inactive Ingredients:

water, mineral oil, stearyl alcohol, decyl oleate, glyceryl stearate, oleth-20, laureth-23, propylene glycol, stearamidopropyl dimethylamine, citric acid, sodium metabisulfite, methylparaben, propylparaben, fragrance

Package Labeling

12022-014-00

NADINOLA SKIN FADEEXTRA
hydroquinone, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12022-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	30 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DECYL OLEATE (UNII: ZGR06DO97T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OLETH-20 (UNII: YTH167I2AG)
LAURETH-23 (UNII: N72LMW566G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12022-014-00	1 in 1 CARTON	06/01/1983	09/03/2020
1		64 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part358A	06/01/1983	09/03/2020

Labeler - J. Strickland & Co. (007023112)

Registrant - J. Strickland & Co. (007023112)

Name	Address	ID/FEI	Business Operations
Establishment
J. Strickland & Co.		007023112	manufacture(12022-014) , pack(12022-014) , label(12022-014)

Revised: 11/2020

Document Id: b34ce02d-9931-6700-e053-2a95a90ad4a6

Set id: 6bab2757-5847-40a4-9980-121cc0cd7da2

Version: 2

Effective Time: 20201104

J. Strickland & Co.