PREPARING TONIC- salicylic acid lotion 
Lange SAS

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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KEY ACTIVE INGREDIENTS
Zinc PCA, Salicyclic Acid, Iris Flower Extract, Stinging Nettle

PREPARING TONIC LOTION
With Sebum-Regulator Zinc PCA,
Anti-Microbial Salicylic Acid and Stinging Nettle

Keep out of reach of children.

PREPARING TONIC LOTION LANGE
LANGE Tonic Lotion will help to minimise pore size with its astringent ingredients and boost sebum regulation with its Zinc PCA extracts. Its Salicylic Acid limits bacterial growht and Stinging Nettle extract is antiseptic and Anti-Inflammatory. Skin is smoother and complexion is brighter with Tonic Lotion main actions:
Clears away dead cells,
Prevents blackheads formation,
Absorbs the excess of sebum.

Not to be used for children under three years of age. Avoid contact with Eyes.
For external use only. If skin has allergic reaction, stop use immediately.

180 ml
6.08 FL. OZ

WATER
PROPYLENE GLYCOL
URTICA DIOICA EXTRACT
SORBITOL
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
ISOBUTYLPARABEN
SODIUM LACTATE
ZINC PCA
POLYSORBATE 80
BENZYL ALCOHOL
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
TRIETHYLENE GLYCOL
MAGNESIUM NITRATE
MAGNESIUM CHLORIDE
TETRASODIUM EDTA
SALICYLIC ACID
PANTHENOL
ALLANTOIN
YELLOW FIVE
ALCOHOL DENAT.
IMIDAZOLIDINYL UREA
CITRIC ACID

Label

PREPARING TONIC 
salicylic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51830-054
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1.8 mg  in 180 mg
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
IMIDUREA (UNII: M629807ATL)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
ALCOHOL (UNII: 3K9958V90M)  
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51830-054-07 180 mg in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 07/18/2012
Labeler - Lange SAS (275956105)
Establishment
Name Address ID/FEI Business Operations
Lange SAS 275956105 manufacture(51830-054)

Revised: 2/2013
Document Id: 23c8b813-23a3-4a5b-bad3-e3a7d8d19896
Set id: 92a7f3ba-ac9b-41d9-bcd7-1a45d0b1782d
Version: 2
Effective Time: 20130212
 
Lange SAS