SALICYLIC ACID 0.5% BODY SERUM- salicylic acid lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

QUESTIONS

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PURPOSE

Acne treatment

WARNINGS

Warnings
For external use only
When using this product  skin irritation and dryness is
more likely to occur if you use another topical acne
medication at the same time. If irritation occurs, only use
one topical acne medication at a time.

DOSAGE & ADMINISTRATION

Directions  clean the skin thoroughly before applying
this product  apply to body and rub in with hands if
needed  allow the product to dry  cover the entire affected
area with a thin layer one to three times daily  because
excessive drying of the skin may occur, start with one
application daily, then gradually increase to two or three
times daily if needed or as directed by a doctor  if
bothersome dryness or peeling occurs, reduce application
to once a day or every other day  avoid contact with eyes,
if contact occurs rinse thoroughly with water.

OTHER SAFETY INFORMATION

Other information
Patch testing prior to use is advised: Apply the product as
directed to a small area once a day for three days to test if you
are sensitive to this product

INACTIVE INGREDIENT

Inactive ingredients
Chlorphenesin, Glycerin, Isoceteth-20, Pentylene Glycol,
Phenoxyethanol, Sarcosine, Sodium Hydroxide, Water.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses
 For the treatment of acne.
 Helps clear up acne blemishes and allows skin to heal.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 0.5% BODY SERUM 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72208-321
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOCETETH-20 (UNII: O020065R7Z)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SARCOSINE (UNII: Z711V88R5F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72208-321-01	1 in 1 BOX	04/30/2026
1		240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/30/2026

Labeler - Deciem (203133665)

Establishment
Name	Address	ID/FEI	Business Operations
Deciem		243327654	manufacture(72208-321) , label(72208-321) , pack(72208-321)

Establishment
Name	Address	ID/FEI	Business Operations
Crystal care cosmetics Inc.		205493484	label(72208-321) , pack(72208-321) , manufacture(72208-321)