Label: YOURGOODSKIN RAPID RESCUE TREATMENT- salicylic acid gel
- NDC Code(s): 68472-237-29, 68472-237-30
- Packager: BOOTS RETAIL USA INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 1, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- GENERAL PRECAUTIONS
- SAFE HANDLING WARNING
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Directions
- Clean the skin thoroughly before applying the product.
- 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.
- Other information
- Inactive Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
YOURGOODSKIN RAPID RESCUE TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68472-237 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO) AMMONIA (UNII: 5138Q19F1X) HEXYLENE GLYCOL (UNII: KEH0A3F75J) LEVOMENOL (UNII: 24WE03BX2T) GREEN TEA LEAF (UNII: W2ZU1RY8B0) WATER (UNII: 059QF0KO0R) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) PANTHENOL (UNII: WV9CM0O67Z) EDETATE SODIUM (UNII: MP1J8420LU) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68472-237-30 1 in 1 CARTON 12/19/2017 1 NDC:68472-237-29 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/19/2017 Labeler - BOOTS RETAIL USA INC (143151533) Registrant - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(68472-237) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth, Inc. 080086802 manufacture(68472-237)