BOTANIC HEAL BoH Acne Sensitive Fo Am Cleanser: Package Insert and Label Information

BOTANIC HEAL BOH ACNE SENSITIVE FO AM CLEANSER- salicylic acid gel
Cj Olivenetworks Co., Ltd

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.

ACTIVE INGREDIENT

Active ingredients: SALICYLIC ACID 0.50%

INACTIVE INGREDIENT

Inactive ingredients: WATER,MYRISTIC ACID,GLYCERIN,POTASSIUM HYDROXIDE,PROPYLENE GLYCOL,STEARIC ACID,LAURIC ACID,PEG-75,GLYCERYL STEARATE,PEG-100 STEARATE,FRAGRANCE,POLOXAMER 184,PHENOXYETHANOL,DISODIUM EDTA

PURPOSE

Purpose: Acne Treatment

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: Hypo-allergenic foam cleanser that helps to recover the sensitive and acne skin.

Directions

Directions: At the last step of basic skincare, turn the dial on the lower part of the container to raise content by 5mm and lightly apply on the face, starting from the inside and working outward.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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BOTANIC HEAL BOH ACNE SENSITIVE FO AM CLEANSER
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71596-037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1.25 g in 250 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71596-037-01 250 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2017
Labeler — Cj Olivenetworks Co., Ltd (688271303)
Registrant — Cj Olivenetworks Co., Ltd (688271303)
Establishment
Name Address ID/FEI Operations
Kolmar Korea Co., Ltd. 689512611 manufacture (71596-037)

Revised: 08/2017 Cj Olivenetworks Co., Ltd

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