NADINOLA SKIN FADE FOR NORMAL SKIN- 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 for Normal Skin

Active Ingredients

Hydroquinone, 2%; Octisalate, 3%

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 broken skin 
  • to prevent sunburn
  • if product is tan or brown.

When using this product,

  • mild irritation may occur 
  • avoid contact with eyes. If contact occurs, rinse with water.
  • avoid unnecessary sun exposure and use a sunscreen or protective clothing

Stop use and consult 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 the 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, glyceryl stearate, PEG-8, isopropyl myristate, isopropyl isostearate, cetyl alcohol, PEG-100 stearate, fragrance, citric acid, methylparaben, propylparaben, sodium bisulfite.

Package Labeling

12022-015-00

NADINOLA SKIN FADE FOR NORMAL SKIN 
hydroquinone, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12022-015-001 in 1 CARTON06/01/198309/24/2020
164 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A06/01/198309/24/2020
Labeler - J. Strickland & Co. (007023112)
Registrant - J. Strickland & Co. (007023112)
Establishment
NameAddressID/FEIBusiness Operations
J. Strickland & Co.007023112manufacture(12022-015) , pack(12022-015) , label(12022-015)

Revised: 11/2020
 
J. Strickland & Co.