GLYCOLIC 35 / LACTIC 45 COMBO PEEL solution

GLYCOLIC 35 / LACTIC 45 Combo Peel by

Drug Labeling and Warnings

GLYCOLIC 35 / LACTIC 45 Combo Peel by is a Otc medication manufactured, distributed, or labeled by Gazebo Wellness SKIN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

AHA PEELS work by loosening and gently sloughing off the damaged. unattractive skin cells, while working on the deeper layers of skin to accelerate the skin's natural production of collagen and elastin.

WARNINGS

DIRECTIONS: Apply the peel to the treatment area. Let stand on skin for 2-10 minutes depending on skin tolerance. Remove peel with copious amount of water. Follow with moisturizer. Note: A stinging sensation may occur. Flakiness may occur for 3-5 days after performing peel. When using this product avoid unnecessary sun exposure and use sunscreen. For external use only.

INACTIVE INGREDIENT

Inactive ingredient: Deionized Water.

INDICATIONS & USAGE

DIRECTIONS: Apply the peel to the treatment area. Let stand on skin for 2-10 minutes depending on skin tolerance. Remove peel with copious amount of water. Follow with moisturizer. Note: A stinging sensation may occur. Flakiness may occur for 3-5 days after performing peel. When using this product avoid unnecessary sun exposure and use sunscreen. For external use only.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PURPOSE

Glycolic Acid 35%
Lactic Acid
45%
Clears Acne & Scars Removes Dead Skin Cells
Smoothes Fine lines & Wrinkles

Distributed By:
Skin Beauty Solutions Elk Grove CA 95759

ACTIVE INGREDIENT

Active ingredients: MD Grade Glycolic Acid, Lactic Acid.

PRINCIPAL DISPLAY PANEL

Content of labeling

INGREDIENTS AND APPEARANCE

GLYCOLIC 35 / LACTIC 45 COMBO PEEL 
glycolic 35 / lactic 45 combo peel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84785-0018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	0.3 mg  in 30 mL
GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S)	GLYCOLIC ACID	0.3 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84785-0018-1	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024
2	NDC: 84785-0018-2	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024
3	NDC: 84785-0018-3	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024
4	NDC: 84785-0018-4	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024
5	NDC: 84785-0018-5	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024
6	NDC: 84785-0018-6	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/01/2024

Labeler - Gazebo Wellness SKIN LLC (119609953)

Registrant - Gazebo Wellness SKIN LLC (119609953)

Establishment
Name	Address	ID/FEI	Business Operations
Gazebo Wellness SKIN LLC		119609953	manufacture(84785-0018)