Label: PACIFICA ACNE WARRIOR BODY SCRUB- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61197-400-00 - Packager: Pacifica Beauty LLC.
- 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 January 8, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer and rinse thoroughly 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.
- sensitivity test for a new user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
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Inactive ingredients
Aqua, Sodium Cocoyl Glutamate, Disodium Cocoyl Glutamate, Hydroxypropyl Starch Phosphate, Hydrolyzed Jojoba Esters, Aloe Barbadensis Leaf Juice1, Decyl Glucoside, Niacinamide, Hamamelis Virginiana (Witch Hazel) Water, Glycerin, Cucumis Sativus (Cucumber) Extract1, Melissa Officinalis Extract, Lavandula Angustifolia (Lavender) Oil, Salvia Officinalis (Sage) Oil, Phenoxyethanol, Ethylhexylglycerin, Parfum2.
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- PRINCIPAL DISPLAY PANEL - 170 g Cup Label
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INGREDIENTS AND APPEARANCE
PACIFICA ACNE WARRIOR BODY SCRUB
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-400 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 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG) Disodium Cocoyl Glutamate (UNII: MBK0CP8F5A) Hydrolyzed Jojoba Esters (Acid Form) (UNII: UDR641JW8W) Aloe Vera Leaf (UNII: ZY81Z83H0X) Decyl Glucoside (UNII: Z17H97EA6Y) Niacinamide (UNII: 25X51I8RD4) Hamamelis Virginiana Top Water (UNII: NT00Y05A2V) Glycerin (UNII: PDC6A3C0OX) Cucumber (UNII: YY7C30VXJT) Melissa Officinalis Whole (UNII: YF70189L0N) Lavender Oil (UNII: ZBP1YXW0H8) Sage Oil (UNII: U27K0H1H2O) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-400-00 170 g in 1 CUP; Type 0: Not a Combination Product 02/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/01/2021 Labeler - Pacifica Beauty LLC. (058549421) Establishment Name Address ID/FEI Business Operations Sun Deep Inc. 189788201 MANUFACTURE(61197-400)
