THAYERS SINCE 1847 NATURAL REMEDIES BLEMISH CLEARING WITCH HAZEL ALOE VERA FORMULA BALM- salicylic acid gel

Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm by

Drug Labeling and Warnings

Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, RNA Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

for the treatment of acne
clears acne blemishes and allows skin to heal
helps prevent the development of new acne blemishes

Warnings

For external use only

When using this product

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 right away.

Directions

• clean the skin thoroughly before applying this 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

store at 15°-30° C (59°-86° F) away from direct sunlight

Inactive ingredients

water, helianthus annuus (sunflower) seed oil, stearic acid, glyceryl stearate, PEG-100 stearate, beeswax, hamamelis virginiana (witch hazel)
bark/leaf/twig extract, aloe barbadensis leaf extract, phenoxyethanol, ethylhexylglycerin, aminomethyl propanol, xanthan gum, carrageenan,
melaleuca alternifolia (tea tree) leaf oil, cymbopogon flexuosus (lemongrass) oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THAYERS SINCE 1847 NATURAL REMEDIES BLEMISH CLEARING WITCH HAZEL ALOE VERA FORMULA BALM 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-530
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
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL DISTEARATE (UNII: 73071MW2KM)
PEG-100 STEARATE (UNII: YD01N1999R)
YELLOW WAX (UNII: 2ZA36H0S2V)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
XANTHAN GUM (UNII: TTV12P4NEE)
CARRAGEENAN (UNII: 5C69YCD2YJ)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-530-01	118 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	01/01/2022

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
RNA Pharma, LLC		079103999	manufacture(49967-530)