ACNEFREE DERMATOLOGY INSPIRED CARE BLACKHEAD REMOVING SCRUB ACNE TREATMENT- salicylic acid gel
Relumins Labs LLC

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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Relumins Pro Clear Soap: Professional Deep Cleaning

Active ingredient

Salicylic acid 2%

Uses

For the treatment of acne

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.

Keep out of reach of children.

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

Directions

Inactive ingredients

cocus nucifera (coconut) oil, purified water, sodium hydroxide, glycine soja, aloe barbadensis leaf extract, olive oil, citrus sinesis oil, glycerin, sodium lactate, sodium glucconate, fragrance, CI 77492, CI 77891, kaolin clay and disodium EDTA

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ACNEFREE DERMATOLOGY INSPIRED CARE BLACKHEAD REMOVING SCRUB ACNE TREATMENT
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79061-259
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SOYBEAN (UNII: L7HT8F1ZOD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLIVE OIL (UNII: 6UYK2W1W1E)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM GLUCONATE (UNII: R6Q3791S76)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79061-259-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	07/31/2018

Labeler - Relumins Labs LLC (081506626)

Name	Address	ID/FEI	Business Operations
Establishment
COSMESTHETIC LABS. CORP.		725862577	MANUFACTURE(79061-259)