SOFTLIPS NATURALS MEDICATED ELDERBERRY ACAI- camphor, menthol stick

Softlips Naturals Medicated Elderberry Acai by

Drug Labeling and Warnings

Softlips Naturals Medicated Elderberry Acai by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Camphor 0.5%

Menthol 1%

Purpose

External analgesic

External analgesic

Uses

• temporarily protects and helps relieve chapped or cracked lips
• for the temporarily relief of pain associated with minor skin irritation, chapped or cracked lips

Warnings

For external use only

When using this product

• do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other Information

• this is a personal care item and should be used by one individual only
• protect this product from excessive heat and direct sun

Inactive ingredients

olea europaea (olive) fruit oil, beeswax, cocos nucifera (coconut) oil, squalane, ricinus communis (castor) seed oil, bis-diglyceryl polyacyladipate-2, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, brassica campestris/aleurites fordi oil copolymer, flavor, helianthus annuus (sunflower) seed oil, argania spinosa [argan] kernel oil, camellia sinensis [green tea] seed oil, glycine soja (soybean) oil, honey [manuka], plukenetia volubilis [sacha inchi] seed oil, rosmarinus officinalis (rosemary) leaf extract, stevia rebaudiana extract, tocopherol [vitamin E]

Questions?

1-877-636-2677 MON-FRI 9AM to 5PM (EST)

Package Label/Principal Display Panel

Package Label/Principal Display Panel

INGREDIENTS AND APPEARANCE

SOFTLIPS NATURALS MEDICATED ELDERBERRY ACAI 
camphor, menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8482
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)
TOCOPHEROL (UNII: R0ZB2556P8)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
GLYCINE SOJA (SOYBEAN) OIL UNSAPONIFIABLES (UNII: WZ7DY7GBV6)
STEVIA REBAUDIANA LEAF (UNII: 6TC6NN0876)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
BEESWAX (UNII: 2ZA36H0S2V)
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL (UNII: 8LGU7VM393)
SQUALANE (UNII: GW89575KF9)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
BRASSICA CAMPESTRIS (RAPESEED) SEED OIL (UNII: N4G8379626)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
HONEY (UNII: Y9H1V576FH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8482-1	2 in 1 BLISTER PACK	05/15/2024
1		4.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/15/2024

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	manufacture(10742-8482)