RESCUE ME ACNE BLEMISH TREATMENT  ORIGINAL FORMULA- salicylic acid gel 
ASPIRE BRANDS INC

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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ASPIRE BRANDS - RESCUE ME ACNE BLEMISH TREATMENT (70626-103)

ACTIVE INGREDIENTS

SALICYLIC ACID 2%

PURPOSE

ACNE TREATMENT

USE

ACNE TREATMENT TO HELP CLEAR UP AND PREVENT NEW ACNE BLEMISHES, BLACKHEADS, AND WHITEHEADS.

WARNINGS

  • FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.
  • 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 IMMEDIATELY.

DIRECTIONS

  • CLEAN THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT.
  • COVER THE ENTIRE 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.

INACTIVE INGREDIENTS

ALCOHOL DENAT., ALLANTOIN, BISABOLOL, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CITRIC ACID, DISODIUM EDTA, FRAGRANCE, GLYCERIN, HYDROXYETHYLCELLULOSE, NORDHYDROGUAIARETIC ACID, OLEANOLOC ACID, PEG-60 ALMOND GLYCERIDES, PEG-40 HYDROGENATED CASTOR OIL, SODIUM HYDROXIDE, WATER.

QUESTIONS/COMMENTS?

1-866-984-1433

25mL_RM_BOX_00540_116mm

25mL_RM_TUBE_1005401

RESCUE ME ACNE BLEMISH TREATMENT   ORIGINAL FORMULA
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70626-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70626-103-511 in 1 BOX04/03/2021
1NDC:70626-103-1125 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/17/201704/03/2021
Labeler - ASPIRE BRANDS INC (832462811)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713manufacture(70626-103)

Revised: 10/2023
Document Id: 06bf4c31-638a-c7c3-e063-6294a90a4471
Set id: 1c116ffc-638c-4889-8f19-486f3ca238b3
Version: 6
Effective Time: 20231002
 
ASPIRE BRANDS INC